“FDA-cleared” is doing a lot of work.

K243330 510(k) · 2025

The Claim

The most expensive object on this page, sold as a laser you use at home. The price asks you to believe it is a clinic in a box.

The Evidence

LYMA Laser PRO, Lyma Life Ltd., cleared through 510(k) as an over-the-counter light-based device for face wrinkles (product code OHS). Lyma Life Ltd. (FDA registration 3015646995) lists “LYMA Laser PRO” under K243330 (FDA registration & listing data), and its AccessGUDID record, DI 05060555753412, gives premarket submission K243330 (AccessGUDID). The original LYMA Laser is a separate clearance, K210823. Clearance is a finding of substantial equivalence to an earlier device. It is not a measure of how much it does, or for whom. The record covers the device; the Starter Kit is how the retailer sells it.

What Made the Cut

Conditional. The 510(k), listing and device identifier record all point to K243330. The condition: clearance is not proof it will work for you, and the price is $5,995.

Who it's for

Someone who has already decided the price is not the question, and wants a device whose clearance is traceable in the FDA's records.

What to check

The retailer's return window before you open it, and that the box you receive says LYMA Laser PRO.

Price

$5,995 at Violet Grey (as listed Oct 14, 2026)

FDA record and specs from the published sources above.

— Clearance not verified

The Claim

The retailer listing calls it “FDA-cleared”. That is a claim worth checking, because the FDA's database is public.

The Evidence

We could not verify which clearance covers this model. No 510(k) or registration listing under Dr. Dennis Gross was found, but a missing name is not a missing clearance: AccessGUDID has a “Drx SpectraLite Faceware” (model BA567210) whose labeler is LED Technologies, Inc., product codes OHS and OLP, marked not in commercial distribution, with no premarket submission number shown (AccessGUDID DI B347BA5672100). LED Technologies holds 510(k)s K171386 (“dpl SpectraLite”, wrinkles) and K183247 (“dpl Faceware”, wrinkles and mild to moderate acne). Its FDA listings (registration 3015974280) show those numbers but no proprietary names, and no record found ties the FaceWare Pro sold today to either one.

What Made the Cut

Pending review. Until an FDA record ties this model to a specific 510(k), the “FDA-cleared” claim stays unverified here.

Who it's for

Not recommended yet. On paper, someone who wants a mask at a mid-range price.

Price

$455 at Dermstore (as listed Oct 14, 2026)

FDA record and specs from the published sources above.

K230293 510(k) · 2023

The Claim

Three light modes, one mask, and a product page headlined “clinically-proven”. The headline is the brand's; the record is the FDA's.

The Evidence

TheraFace Mask, Therabody, Inc., cleared through 510(k) as an over-the-counter device (product codes OHS and OLP). Per the indications on file, the red and red + infrared modes are cleared for full-face wrinkles, and the blue mode is cleared for mild to moderate inflammatory acne. Therabody (FDA registration 3012386142) lists “TheraFace Mask” and “TheraFace Mask Glo” under K230293 (FDA registration & listing data). Its AccessGUDID record (DI 00840295401720) carries the same product codes but shows no submission number. Clearance is not a measure of results.

What Made the Cut

Conditional. The 510(k) and the company's listing point to the same mask. The condition: clearance is not proof it will work for you.

Who it's for

Someone who wants a clearance on file that is tied to the mask they are buying.

What to check

Which mode you want, the brand's return terms, and the use instructions on the label you receive.

Price

$649.99 at Therabody (as listed Oct 14, 2026)

FDA record and specs from the published sources above.

K171323 510(k) · 2017 · listed

The Claim

A flexible panel with a family name that carries FDA history. The question is whether the history belongs to this model.

The Evidence

Both 510(k)s are for the Biophotas Celluma3: K171323 (decided Sep 1, 2017) for full-face wrinkles, over the counter, and K152280 for periorbital wrinkles, mild to moderate inflammatory acne and temporary relief of minor muscle and joint pain. Biophotas (FDA registration 3009765778) lists “Celluma LITE” and “Celluma Series 2 LITE” as proprietary names under both numbers (FDA registration & listing data). AccessGUDID has a “Celluma Lite C/US” with no premarket submission number shown (DI 00850523007204) and a “Series 2 LITE C/US” that gives K152280 and K171323 (DI 00850523007723). Celluma RESTORE's K211038 is a hair-growth clearance (product code OAP); its listing does not include the LITE.

What Made the Cut

Conditional. The FDA's listing records tie the LITE to the Celluma3 clearances. The condition: a listing is the company's declaration, not a separate FDA review, and clearance is not proof it will work for you.

Who it's for

Someone who prefers a flexible panel to a mask.

Price

$1,195 at DOTSHOP (confirmed by Regina Duke from a DOTSHOP screenshot, Oct 14, 2026)

FDA record and specs from the published sources above.