Solaris Extended Safety FAQ

Important notice, scope, and limitations

Solaris Laboratories NY devices are designed and marketed for cosmetic and wellness use only, not medical diagnosis, not medical treatment, not cure, not prevention of disease. This positioning aligns with the FDA Center for Devices and Radiological Health’s General Wellness policy for low risk products. Users must follow all instructions, observe all warnings, and consult a physician if uncertain. (U.S. Food and Drug Administration)

1. User duties, global precautions, and baseline rules

• External use only, never internal, never on mucous membranes, never in eyes, ears, mouth, or genitals.
  
• Use only on intact, healthy skin or scalp, the device is not for open wounds, infections, recent stitches, or post-procedure skin until cleared by a clinician.
  
• Read the instruction manual in full before first use, confirm you understand controls, timers, and safety notes, do not modify or bypass any safety feature.
  
• Patch test is mandatory for all users and all devices, test on a small area for a short duration, wait 24 hours, discontinue if irritation persists.
  
• Keep out of reach of children and pets, devices are not toys, small parts and chargers present choking and strangulation hazards.
  
• Do not use while driving, bathing, showering, sleeping, intoxicated, or if your judgment or sensation is impaired.
  
• If you do not understand any instruction, do not use, contact customer support for clarification.
  

If adverse effects occur

• If you experience unexpected heat, pain, persistent redness, swelling, or visual disturbance, stop immediately, remove the device, allow the area to recover, and consult a physician.
  
• If any device shows cracking, swelling, odor, abnormal sound, or erratic operation, stop using it and contact customer support.
  

2. Electrical, lithium battery, charging, and fire safety

Most Solaris devices are rechargeable lithium powered, charged by USB, intended for 5 V power sources only. The safest practice is conservative charging, controlled environment, and supervision.

Charging environment and supervision

• Charge only on a flat, stable, non-flammable surface, keep away from bedding, fabrics, paper, curtains, and aerosols.
  
• Never charge unattended, not overnight, not while asleep, not while away, unplug when full, do not leave connected past charge time.
  
• Use only 5 V USB power, do not use “fast charge” (apple, samsung) adapters that exceed 5 V, do not use visibly damaged cables or bricks, avoid multi-tap, avoid daisy-chained extension cords.
  

Thermal and mechanical risk management

• Do not charge on soft or insulating surfaces that trap heat, do not cover a charging device, maintain ventilation.
  
• Do not crush, puncture, disassemble, or expose to flame or direct sun, do not leave in vehicles in heat, avoid freezing conditions except for cryo products specifically intended for cooling.
  
• If a device becomes unusually warm during charge, emits odor, swells, hisses, or discolors, move it to a non-flammable surface, disconnect from power if safe, do not handle further, contact support.
  

Authority basis and rationale

• Consumer incidents with lithium batteries typically involve misuse, damaged cells, or incompatible charging hardware, see CPSC guidance on overheating and fire hazards for batteries and chargers. Your instructions above reflect those precautions. (U.S. Consumer Product Safety Commission)
  

3. Light therapy, red, blue, near-infrared, exposure limits, and protective eyewear

Spectral ranges and device output

• Solaris light devices emit in red, approximately 630 to 670 nm, blue, approximately 420 to 470 nm, and near-infrared, approximately 830 to 850 nm. Near-infrared is part of the infrared spectrum, IR-A 780 to 1400 nm per ICNIRP. (ICNIRP)
  
• Effective surface irradiance for consumer cosmetic use is in the approximately 20 to 40 mW per square centimeter band under normal treatment distances and durations. Sessions are limited by automatic timers.
  

Exposure management by design

• The automatic shutoff limits single session exposure. Users must not bypass timers, must not stack sessions without rest, must follow per-mode guidance in the IFU.
  
• Do not stare into emitters, even briefly. Infrared is invisible and still active when its mode is engaged.
  

Photobiological safety frameworks

• Lamps and LEDs are evaluated under IEC 62471, which defines measurement methods, exposure limits, and risk groups for incoherent broadband sources, including LEDs and infrared, used to classify general biophotonic risk. Consumer class LED beauty devices are designed to sit within low risk outcomes when used as directed. (IEC Webstore, Advanced Illumination)
  
  

Blackout goggles, purpose and mechanism

• Every light therapy product includes fully opaque blackout goggles. This is not a translucent sunglass lens, it is a non-transmissive barrier that eliminates a direct line of sight to the emitters.
  
• Why blackout and not see-through lenses, because industrial standards like ANSI Z87.1 govern clear or tinted eyewear for occupational hazards where some light transmission is permitted and controlled by optical density. Your use case is consumer cosmetic, the goal is elimination of emitted light reaching the eye, achieved by blackout construction and closed lids. OSHA recognizes ANSI Z87.1 as the benchmark for occupational eye protection, which illustrates the distinction, but blackout goggles are not within that transmissive testing scope. (OSHA)
  
• Users must wear the blackout goggles, must keep eyes closed under the goggles, must avoid any attempt to verify modes by peeking at the LEDs. Infrared remains active despite being invisible.
  

If goggles are lost or damaged

• Do not substitute sunglasses or lightly tinted safety glasses, those are not sufficient.
  
• Order replacement blackout goggles, do not operate a light device without them.
  

4. Microcurrent, electrical exposure to skin and scalp

Operating range and sensation

• Solaris microcurrent devices operate at approximately 390 to 396 microamperes under typical load, which is non-hazardous for intact skin, commonly felt as mild tingling or no sensation.
  

Mandatory contraindications and physician clearance

• Do not use with pacemakers, implanted defibrillators, deep brain stimulators, cochlear implants, or any electronic implant, risk of interference is not excluded.
  
• Do not use if pregnant or breastfeeding without clinician clearance.
  
• Do not use with epileptic seizure history without clinician clearance.
  
• Do not use over malignant lesions, active infections, or on areas with impaired sensation.
  
• Use conductive media if required by the IFU, do not apply on broken skin.
  
• Stop use if you experience pain, dizziness, palpitations, or unusual muscle contractions.
  

5. Heat, cryotherapy, and temperature hazards

Heat features

• The LED Gua Sha model includes controlled warming, users should feel gentle warmth only, if heat feels excessive, stop immediately, allow the device to cool, inspect for damage, contact support.
  
• No other Solaris device should generate sustained heat. Any unexpected heat indicates potential fault, discontinue use.
  

Cryotherapy products

• Non-electronic cryo devices are chilled in a freezer. Over-cooling can increase risk of cold injury, follow time limits, if a device feels painfully cold, allow it to warm, consider a thin cloth barrier to reduce conductive shock.
  
• Microwave warmed cryo devices must be heated in 10 second intervals only, perform hand touch checks before application, discontinue heating if device becomes hot, swollen, or deforms.
  

Cold and heat sensitivity, expanded cautions

• Individuals with Raynaud’s, cold urticaria, peripheral neuropathy, diabetes-related loss of sensation, poor circulation, or active dermatitis should obtain clinician guidance before heat or cold exposure.
  
• Do not apply heat or cold continuously, respect rest intervals to restore skin temperature and perfusion.
  

6. Vibration and mechanical stimulation, skin and scalp

• Devices with vibration or mechanical movement are designed for gentle stimulation. Pressing with force can cause bruising or irritation, use light contact.
  
• Prevent tangling, avoid use on knotted hair, remove long earrings, keep away from necklaces and loose scarves.
  
• Do not use on inflamed scalp, folliculitis, active psoriasis flares, or fresh transplants.
  
• If hair pulls or discomfort occur, stop, detangle, reassess technique.
  

7. Skin sensitivity, patch testing, topical interactions

• Patch test for each device, and again after changing routines or products, because AHA, BHA, retinoids, benzoyl peroxide, and photosensitizing prescriptions can increase reactivity.
  
• Suspend use on areas recently waxed, dermaplaned, microneedled, or peeled until the skin barrier is restored.
  
• Known photosensitizers and conditions require caution for light use, examples include tetracyclines, sulfonamides, isotretinoin history, St. John’s Wort, porphyria, lupus. Obtain clinician guidance.
  

8. Eyes and vision, conservative policy

• Light devices must always be operated with blackout goggles, eyes closed, avoid direct viewing.
  
• Individuals with known eye disease, glaucoma, retinal disorders, recent eye surgery, dry eye with corneal compromise, or any active ophthalmic condition must obtain physician clearance before any light exposure near the periocular area.
  
• FDA regulates impact resistance for ophthalmic lenses under 21 CFR 801.410. That regulation illustrates the federal emphasis on eyewear safety for transmissive lenses, which is distinct from your blackout non-transmissive goggles used for consumer light devices. (eCFR, U.S. Food and Drug Administration)
  

9. Wet locations, bathrooms, steam, and water

• Do not use or charge any device in showers, tubs, saunas, steam rooms, near sinks, or on wet counters.
  
• Water and steam increase electrical hazard and corrosion risk, also reduce skin barrier integrity which may amplify sensations.
  
• If a device is submerged or soaked, discontinue use, do not charge it, contact support for evaluation.
  

10. Environment, storage, transport, and travel

• Store devices in a cool, dry place, away from direct sunlight, radiators, stoves, or car dashboards.
  
• Do not leave devices on window sills or in parked cars, thermal cycling can stress casings and batteries.
  
• For flights, follow airline rules for lithium batteries in carry-on only, not checked baggage, protect terminals, power off.
  
• At hotels, charge only while awake and present, on a hard non-flammable surface.
  

11. Claims, performance expectations, and result disclaimers

• Solaris devices are cosmetic and wellness tools only, they are not medical devices, not FDA cleared for treatment of disease, not substitutes for professional care. (U.S. Food and Drug Administration)
  
• Marketing claims are limited to appearance improvements, for example fine line appearance, cosmetic skin tone evenness, visible reduction in shedding, cosmetic volume and density appearance.
  
• No permanent outcomes are promised, results vary by individual, age, skin type, hair type, and adherence to instructions.
  
• Do not infer medical benefits, no disease claims are made.
  

12. Contraindications, consolidated and modality specific

Applies to all devices

• Pacemakers, implanted defibrillators, electronic implants unless cleared by the managing physician
  
• Pregnancy or breastfeeding unless cleared by a clinician
  
• Epilepsy or seizure disorder unless cleared
  
• Active cancer unless cleared
  
• Open wounds, active infections, severe dermatitis in the area
  
• Post operative or post procedure areas until medically cleared
  

Light therapy specific

• Eye disease, recent eye surgery, retinal disorders without ophthalmologist clearance
  
• Known photosensitivity disorders or use of photosensitizing medications without clinician guidance
  

Microcurrent specific

• Any implanted electronic device, regions of the body with impaired sensation, over the carotid sinus, across the chest in cardiac disease, malignancy sites
  

Heat and cryo specific

• Raynaud’s, cold urticaria, peripheral neuropathy, vascular insufficiency, conditions with impaired heat dissipation, do not apply prolonged heat or extreme cold
  

13. Cleaning, maintenance, inspection, and serviceability

• Power off before cleaning, disconnect from chargers, wipe with a lightly damp soft cloth, mild soap if needed, no solvents, no alcohol on lenses or silicone unless the IFU permits it.
  
• Do not allow liquids to ingress into ports, buttons, or seams.
  
• Inspect devices before each use, stop using if you see cracks, exposed wiring, loose parts, swollen batteries, or damaged silicone.
  
• Goggles, if torn, warped, or deformed, must be replaced, do not attempt repairs.
  
• Do not modify devices, do not install non-approved parts, do not cover vents.
  

14. Blackout goggles, extended technical note

• Functional objective, eliminate direct optical path from LEDs to eyes during operation.
  
• Construction goal, non transmissive opaque barrier made from suitable polymer or silicone thickness, combined with closed eyelids, yields practical elimination of visible and near-infrared exposure at consumer device power levels.
  
• Standards context, ANSI Z87.1 is the OSHA recognized framework for occupational eye and face protection where performance is measured on transmissive lenses for impact and spectral transmission, your goggles are non-transmissive blackout barriers for cosmetic devices, hence the industrial standard is not directly applicable. (OSHA)
  
• Users must wear goggles for every light session, keep eyes closed, avoid any attempt to identify modes by viewing the light source.
  

15. Photobiological risk context and why timers matter

• IEC 62471 provides exposure limits and classification methods for LEDs and infrared lamps used in consumer and professional products, risk outcomes depend on intensity, exposure duration, and distance. Timers and mode instructions keep consumer exposures well within low risk operating envelopes. (IEC Webstore, Advanced Illumination)
  
• ICNIRP visible and infrared guidelines address ocular and skin limits for incoherent sources, the conservative use instructions above, blackout eyewear, and the 10 minute timer collectively reduce exposure far below occupational hazard scenarios. (ICNIRP)
  

16. Wet use prohibitions and shock avoidance

• Never use devices while bathing or showering, never immerse any rechargeable unit, water increases shock and corrosion risks and also undermines hygienic control.
  
• Do not operate with wet hands, do not place charging cables where they can contact sinks or puddles.
  
• If a device is dropped in water, do not turn it on, do not charge it, allow it to dry and contact support for evaluation.
  

17. Documentation, records, and model identification

• Keep purchase receipts, serial numbers, and batch codes, store manuals and safety inserts.
  
• Photograph the product label and serial number for your records.
  
• If you report a safety concern, provide model, serial, purchase date, and description of use conditions.
  

18. Warranty and limitation of liability, summary

• Solaris provides a limited warranty for manufacturing defects, details in the product IFU and site terms.
  
• Warranty does not cover misuse, overuse, charging with non-compliant adapters, use in wet locations, ignoring contraindications, or self-repair.
  
• Remedies are limited to repair or replacement of the device as permitted by law.
  
• Solaris is not liable for incidental, indirect, or consequential damages arising from misuse or failure to follow instructions.
  

19. Authority references, for context

• FDA, General Wellness, Policy for Low Risk Devices, describes low risk products that promote a healthy lifestyle and the FDA’s compliance posture, relevant to cosmetic and wellness positioning. (U.S. Food and Drug Administration)
  
• OSHA page on Eye and Face Protection lists ANSI Z87.1 as the U.S. benchmark for occupational protective eyewear, which clarifies the transmissive-lens context versus blackout goggles used here. (OSHA)
  
• ICNIRP Guidelines on Limits of Exposure to Incoherent Visible and Infrared Radiation, Health Physics 2013, provide exposure limits for non-laser LEDs and infrared sources that inform conservative consumer practices. (ICNIRP)
  
• IEC 62471 standard defines evaluation of photobiological safety for lamps and LEDs, exposure limits, measurement methods, and risk groups, used widely to characterize LED safety. (IEC Webstore, Advanced Illumination)
  
• CPSC, batteries and chargers, summarizes consumer risk patterns like overheating and fire from mismanaged charging and non-compliant hardware, which underpins the charging precautions here. (U.S. Consumer Product Safety Commission)
  

20. Final reminders

• Cosmetic wellness use only, follow timers and distances, wear blackout goggles for all light sessions, keep away from water, use only 5 V chargers, supervise charging, stop if anything feels wrong.
  
• If uncertain, consult your physician before use, this single step resolves most borderline cases and is consistent with best practice across consumer wellness products.
  

The irradiance value (30-40 mW/cm²) indicates the energy delivered per second to a square centimeter of the treated area.

This combination of wavelengths is designed for:

630 + 660 nm (Red): Stimulating collagen production, enhancing blood flow, and supporting healing.

420 nm (Blue): Targeting acne-causing bacteria and calming skin.

This device offers a balanced energy level suitable for safe and effective use on the scalp or skin. Let me know if you need more technical details!

If you’re experiencing issues with charging, follow these steps to troubleshoot:

Please view this video HERE and read the below:

Avoid Apple Chargers:

Do not use an Apple charger, as its higher output can affect the hat’s battery. Instead, use a generic 5V 1/2Amp USB plug with the magnetic charging cord included in your box.

Magnetic Charger:

• Connect the magnetic charge cord to your hat and plug it into a generic USB plug.
• Charge the hat for 4 hours. While charging, the light will blink red. Once fully charged, the light will turn solid red.
• When unplugged, the light should turn off completely. If it stays solid red after unplugging, please contact our customer service team.

USB Type-C Charging Option:

• If the magnetic charging cord doesn’t work or seems glitchy, unplug (you can just pull it out ) the small round disk attached to the hat insert. This will reveal a USB Type-C (apple cord) port on the LED insert.
• Use any USB Type-C cable (not an Apple plug) to charge your hat. The charging time and indicator lights are the same: blinking red while charging, solid red when complete, and off when unplugged.

Important Note: Ensure you try both charging methods (magnetic cord and USB Type-C) before reaching out to customer service. If the light continues to glow red after being unplugged, or if you’re unable to charge the hat using either method, please contact us for further assistance.

If the LED insert is glowing red after being unplugged, follow these steps to troubleshoot:

1. Check the Charging Methods:

• First, try charging the hat using the magnetic charge cord included in the box. Ensure it’s connected to a generic USB plug (not an Apple charger). Charge for 4 hours until the light changes from blinking red (charging) to solid red (fully charged).
• If the magnetic cord doesn’t work, unplug the small round disk on the hat mat to reveal the USB Type-C port. Use any USB Type-C cable with a generic USB plug to charge the hat.

1. Verify Charging Behavior:During charging, the light should blink red. When fully charged, it will turn solid red end eventually shut off. Once unplugged, the light should turn off completely.
2. Contact Customer Service:

If the light continues to glow red after being unplugged, even after trying both charging methods, please contact our customer service team for assistance please have your order number ready and if you can include a quick 15 second video how you have the hat on plug, unplug it and show how it glows red. Also be sure to mention the steps you’ve already tried to help us resolve the issue quickly.

We’re here to make sure your product functions as it should!

Your hat should be used 3-5 times a week for one 10 minute daily sessions. Please use it on clean dry hair. One charge should work 4-8 sessions total.

Charging your hat is simple! Follow these steps:

Magnetic Charging (Cord included):

1. Connect the magnetic charging cord to the charging port on the hat.
2. Plug the USB end of the cord into any standard USB plug adapter that is 5V 1 or 2 A (amps) (not included). Make sure to avoid using an Apple charger, as its higher output can affect the battery.

USB Type-C Charging Option:

• If you prefer, you can remove the tiny magnetic disk from the hat insert to reveal the USB Type-C port underneath.
• Use any USB Type-C cable with a standard USB plug adapter to charge your hat. Again, avoid using Apple chargers.following the 5V 1/2A USB plug.

Charging Time and Behavior:

• Charge for approximately 4 hours.
• While charging, the indicator light will blink red. Once fully charged, the light will turn solid red.
• After charging, unplug the hat from the power source. The hat will not function while plugged in.

For optimal performance, always ensure the hat is fully charged and unplugged before use!

Charge your hat whenever the hat does not power on if it hasn’t been charged recently.

Here’s a general guideline:

• After a full 4-hour charge, the hat should hold enough power for 4-8 sessions, depending on usage. Remember it shuts off after 10 minutes of use.
• If the hat doesn’t turn on or the lights blink unexpectedly, it’s time to recharge.
• If there is a solid red light when unplugged and not powered on troubleshoot the 'My insert glows red when unplugged' guide.

Tip: Avoid overcharging. Once fully charged (solid red light), unplug it to preserve battery health, as the hat won’t function while plugged in.

Cleaning your hat is simple and helps maintain hygiene. Follow these steps:

Remove the Insert:

Carefully take out the LED insert from the hat before cleaning.

1. Wipe Down:

Use a damp cloth to gently clean the surface of the hat and the LED insert.

The hat is not waterproof, so avoid soaking it or exposing it to excessive moisture.

1. Sanitize (Optional):

For extra cleanliness, use a small amount of alcohol on a cloth to sanitize the insert.

Recommendation: Clean your hat once a week or as needed. Ensure it is completely dry before reassembling and using.

Zero! We have tested it for your safety and it emits no EMF!

With our hat you have one month to use it and or change your mind! you also have a 1 year warranty that just requires your proof of purchase - no registration needed.

Yes! feel free to continue your treatment plans but ensure you use this on clean dry hair with no serum or product on the scalp. If you are unsure or you have a special condition always consult with a medical provider.

1. LED Hat:

• Designed for hands-free use and provides full scalp coverage.
• Uses 630 nm + 660 nm red light and 420 nm blue light for hair follicle stimulation and scalp health.
• Ideal for passive treatments while multitasking.
• Recommended usage: 10 minutes per session, 3–5 times a week.

1. LED Brush:

• Combines red light therapy with a vibrating massage to enhance blood circulation and improve absorption of scalp treatments.
• Targets specific areas of concern (e.g., thinning spots).
• Ideal for users who want manual stimulation alongside light therapy.

1. Cloud 9 Massager:

• Offers red light therapy, vibration, and massage therapy prongs.
• Focuses on scalp relaxation and circulation improvement, making it a great choice for scalp health and stress relief.
• More versatile for scalp massage, but covers less surface area compared to the hat.

Key Difference: The hat delivers a broader, hands-free treatment, while the brush and Cloud 9 provide targeted therapy and additional features like massage for a more focused or interactive experience. Each tool suits different preferences and routines.