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By Regina Duke, editor · Records checked Oct 14, 2026
Light devices are sold in the language of the clinic: wavelengths, sessions, clearance. Two of those words can be checked. This file checks them.
The Claim
“FDA-cleared” sounds like a verdict. It reads like approval, and it lets a mask carry the authority of a doctor's office.
The Evidence
Each record below was opened on the FDA 510(k) database on Oct 14, 2026: device name, applicant, decision date, product code and cleared use. Cleared uses are given in the FDA's indication terms, nothing broader.
| Product | Price · retailer | FDA status | Cleared for | Verdict |
|---|---|---|---|---|
| LYMA Laser Pro Starter Kit | $5,995 · Violet Grey | Cleared, 510(k) K243330 | Face wrinkles (over the counter) | Conditional |
| Dr. Dennis Gross DRx SpectraLite FaceWare Pro | $455 · Dermstore | FDA record not yet found | Not verified | Pending FDA record |
| Therabody TheraFace Mask | $649.99 · Therabody | Cleared, 510(k) K230293 | Full-face wrinkles (red; red + infrared) and acne (blue light) | Conditional |
| Celluma LITE LED Device | $1,195 · DOTSHOP | Not confirmed for LITE (Celluma3: K171323) | Celluma3: full-face wrinkles. LITE: not confirmed | Pending review |
What Made the Cut
No device here is upheld. A clearance is a regulatory finding, not a result. Two records match their products by name. Two can't yet be tied to the product on sale.
Upheld = the record and listing hold up to the bar. It is not a validation of every marketing claim. Conditional = the record matches the product, with a caveat. Pending review / Pending FDA record = the FDA claim can't be tied to this exact product yet, so it isn't recommended. How verdicts are made.
K243330510(k) · 2025
FDA status: 510(k) K243330, “LYMA Laser PRO”, Lyma Life Ltd., decided Feb 21, 2025
LYMA Laser Pro Starter Kit
- 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
- The FDA record matches the device by name: LYMA Laser PRO, cleared through 510(k) as an over-the-counter light-based device for face wrinkles (product code OHS). 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 FDA record matches the device by name. 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 510(k) names it exactly.
- 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)
Shop at Violet Grey Affiliate link: THE RECORD may earn a commission.
Used by the editor. FDA record and specs from the published sources above.
—No record found
FDA status: FDA record not yet found
Dr. Dennis Gross DRx SpectraLite FaceWare Pro
- The Claim
- The retailer listing calls it “FDA-cleared”. That is a claim worth checking, because the FDA's database is public.
- The Evidence
- FDA record not yet found. A search of the 510(k) database under this name and brand returned no exact match. Two records from another company, LED Technologies, Inc., carry similar names (“dpl SpectraLite”, K171386, and “dpl Faceware”, K183247). Neither names this product or this brand, so THE RECORD does not count either as this device's clearance.
- What Made the Cut
- Pending FDA record. Until a 510(k) that names this device is found, 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.
- What to check
- Ask the seller for the 510(k) number, then look it up yourself on the FDA database.
- Price
- $455 at Dermstore (as listed Oct 14, 2026)
Verdict pending verification.
Used by the editor. FDA record and specs from the published sources above.
K230293510(k) · 2023
FDA status: 510(k) K230293, “TheraFace Mask”, Therabody, Inc., decided Jun 9, 2023
Therabody TheraFace Mask
- 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
- The FDA record matches by name and company: 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 acne. Clearance is not a measure of results.
- What Made the Cut
- Conditional. The paperwork matches the product exactly, which is more than most of the category can say. The condition: clearance is not proof it will work for you.
- Who it's for
- Someone who wants the clearance on file to name the exact 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)
Shop at Therabody Affiliate link: THE RECORD may earn a commission.
Used by the editor. FDA record and specs from the published sources above.
LITERecord not confirmed
FDA status: Not confirmed for the LITE. Record found for K171323, “Biophotas Celluma3”, Biophotas, Inc., decided Sep 1, 2017
Celluma LITE LED Device
- 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
- The FDA record K171323 is for the Biophotas Celluma3, cleared for full-face wrinkles over the counter. Other Celluma models have their own records. THE RECORD found none that names the LITE, so the Celluma3 clearance is not counted as the LITE's.
- What Made the Cut
- Pending review. The brand's clearance history is real; its link to this model is not confirmed. No recommendation until it is.
- Who it's for
- Not recommended yet. On paper, someone who prefers a flexible panel to a mask.
- What to check
- Ask the seller which 510(k) covers the LITE by name before you buy.
- Price
- $1,195 at DOTSHOP (confirmed by Regina Duke from a DOTSHOP screenshot, Oct 14, 2026)
Verdict pending verification.
Used by the editor. FDA record and specs from the published sources above.
Before you buy any of them
- Ask for the 510(k) number. Look it up on the FDA 510(k) database.
- Check that the device name on the record matches the name on the box.
- Read what it was cleared for. Anything the marketing adds beyond that is marketing.
- Read the return policy before you open the box. These are expensive to be wrong about.
This page is information, not medical advice. For any skin condition, see a board-certified dermatologist.
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