FDA-Cleared Red Light Therapy Devices: The 510(k) List (2026)

Twelve FDA 510(k) clearances cover the red light devices we track, and every one belongs to a face mask, a skincare wand or a laser hair cap. No full-body panel in our database holds one. We pulled each K-number from the FDA's own records on October 29, 2026, and every number below links to its entry so you can check it yourself.

The short version: if you want a cleared device for fine lines, the Omnilux Contour Face holds a clearance and measures close to its claimed output. If you also treat inflammatory acne, the Shark CryoGlow is cleared for both. For hair loss, the iRestore Essential is the cheapest cleared laser cap we track.

Cleared, Registered and Approved Mean Different Things

Brands use these three words as if they were the same. They aren't, and most misleading claims in this category trade on the difference.

• FDA cleared means the device went through the 510(k) pathway. The maker showed the FDA that the device is substantially equivalent to one already legally sold, for a stated intended use. Every device on this list is cleared.
• FDA registered means the company told the FDA it makes or sells medical devices, and listed them. The FDA does not review whether a registered device works. Panel brands lean on this word.
• FDA approved refers to premarket approval (PMA), the strictest pathway, used for high-risk devices. No consumer red light device we track is approved. A brand that says "FDA approved" is overstating its status.

There is a fourth category worth knowing. Under the FDA's general wellness policy, low-risk products that make only wellness claims, such as "supports recovery," don't need clearance at all. Many panels, belts and handhelds sell under that policy.

The Full List of Cleared Devices

Each row below was verified against the FDA 510(k) database. The applicant is often the contract manufacturer rather than the brand on the box, which is normal.

Device	510(k)	Cleared	Product code	Applicant on record
Omnilux Contour Face	K191629	Sep 2019	OHS	Ismart Marketing Svcs (as "faceLITE")
CurrentBody Skin LED Mask Series 2	K250966	Jun 2025	OHS	Shenzhen Kaiyan Medical Equipment
CurrentBody 4 in 1 Zone Facial Mapping Mask	K242593	Feb 2025	OHS	Shenzhen Kaiyan Medical Equipment
Shark CryoGlow	K242796	Nov 2024	OHS	SharkNinja Operating
Solawave Wrinkle Retreat Pro	K252983	Dec 2025	OHS	Shenzhen Goodwind Technology
Solawave Radiant Renewal Wand	K232863	Dec 2023	OHS	Shenzhen Kaiyan Medical Equipment
Qure Q-Rejuvalight Pro	K230042	Apr 2023	OHS	Light Tree Ventures Europe
iRestore Essential (ID-500)	K213094	Dec 2021	OAP	Freedom Laser Therapy
iRestore Elite (ID-510)	K222081	Oct 2022	OAP	Freedom Laser Therapy
iRestore Professional 282	K183417	May 2019	OAP	Freedom Laser Therapy
iRestore (original)	K151662	Jan 2016	OAP	Freedom Laser Therapy
Kiierr 272 and 148 Laser	K181878	Sep 2018	OAP	Kiierr International

Two product codes cover everything here. OHS is light-based over-the-counter wrinkle reduction, regulated under 21 CFR 878.4810. OAP covers laser combs and caps for androgenetic alopecia, under 21 CFR 890.5500. The FDA's database lists 163 OHS clearances and 115 OAP clearances in total, so this table is the subset we track, not the whole market.

The Omnilux row carries one caveat. Its clearance is filed under the name "faceLITE," and FDA device and adverse-event records tie the same manufacturer and product code to the Contour Face. We rate that link high-confidence, not manufacturer-confirmed.

Cleared Face Masks and Wands

Every mask and wand above is cleared for wrinkle reduction. Two of them, the Shark CryoGlow and the Qure, are also cleared for mild-to-moderate inflammatory acne. Clearance answers whether the device passed a review. It doesn't answer whether the unit on your face delivers enough light, so we check independent spectrometer measurements as well.

Omnilux Contour Face

The Omnilux pairs 633nm red with 830nm near-infrared, the combination with the most photorejuvenation evidence. Omnilux states about 30 mW/cm², and independent measurement puts it near 28 mW/cm². That is the smallest claimed-versus-measured gap of any mask we track. It has no blue channel, so it treats wrinkles and texture, not acne.

Shark CryoGlow

The CryoGlow is the cleared pick for anyone fighting acne and fine lines at once. It runs 415nm blue, 630nm red and 830nm near-infrared, plus an under-eye cooling plate. Shark's spec sheet mislabels the blue channel as 630nm; an independent measurement found 415nm, the acne standard. No independent irradiance figure has been published yet, so treat its output as unverified.

The CurrentBody Series 2 holds the most recent clean clearance of the full-face masks, from June 2025. It measured 18.5 mW/cm² against a claimed 30, which still clears the effective range. Our LED face mask guide compares all four recommended masks in depth.

The Cleared Mask We Don't Recommend

The Qure Q-Rejuvalight Pro is a useful warning. It holds a genuine clearance, K230042, for wrinkles and acne. Spectrometer testing measured it at 5 to 11 mW/cm², around 8 on average, against a claimed 70 mW/cm². At that output, a normal session falls short of the doses used in the positive trials. The clearance is real, and the light output is far lower than advertised.

Cleared Laser Hair Caps

Laser caps are the other place where clearance is common. All the caps on this list run near 650nm, the red band used in the hair-growth trials.

iRestore Essential (ID-500)

The iRestore Essential is the cheapest cleared cap we track, in the $450 to $500 range. It pairs 51 lasers with 69 LEDs. iRestore holds four OAP clearances across its line, and the Professional 282 and Elite models each carry their own K-number.

Kiierr 272 Premier

The Kiierr is laser-only, with 272 diodes and no LEDs, and its clearance covers both the 272 and the smaller 148. It costs more than the iRestore Essential, partly for the laser-only design and its 210-day money-back guarantee. Our hair growth evidence review covers the trials and who is likely to respond.

Why No Full-Body Panel Makes the List

We found no 510(k) clearance for any of the five panels in our database: Joovv, Mito Red, Hooga, PlatinumLED and Bestqool. Most panels never go through a review at all.

Joovv is the clearest example. Its Solo 3.0 is registered and listed under product code ILY, "Lamp, Infrared, Therapeutic Heating," regulated under 21 CFR 890.5500. That category is exempt from 510(k) review, so a panel can be a listed Class II device without anyone at the FDA reviewing whether it works. Other brands say "FDA Class II registered" or "made in an FDA-registered facility." Both describe registration, not clearance.

Some panel brands go further. A May 2025 investigation by Truth in Advertising found one panel maker misusing the FDA logo and claiming "FDA approved." Our device database records the exact FDA status each brand claims, next to what the public record shows.

None of this means panels don't work. Many panels measure well and match the doses used in trials, and our panel guide ranks them on measured output. It means "FDA" on a panel's product page tells you nothing about results.

How to Check Any Device Yourself

You can verify a clearance claim in about two minutes.

1. Ask the brand for the 510(k) number. It starts with a K followed by six digits.
2. Open the FDA 510(k) database and enter the number.
3. Check that the device name matches the product, or a clearly related model.
4. Check the product code. OHS covers wrinkles, OAP covers hair loss and OLP covers acne.
5. Treat the claim as unverified if the brand gives no number or the record names a different device.

A registration number is not a K-number. If a brand offers a "registration #" instead, it is telling you about the company, not the device.

What Clearance Doesn't Tell You

A 510(k) clearance is a real review and a higher bar than registration. It still leaves three questions open. It doesn't confirm that the unit you buy delivers its claimed irradiance, as the Qure shows. It doesn't confirm that results match the effect sizes in published trials. And it covers only the cleared use: a wrinkle clearance says nothing about pain, sleep or weight loss.

Use clearance as the first filter, then check measured output and the evidence for your specific goal. Our methodology page explains how we weigh those three sources.