Laser caps for hair loss: every FDA clearance, brand by brand

Last reviewed July 2026.

Laser and LED caps for hair loss are regulated devices, and the FDA keeps a public list of every one it has cleared. They sit under a single product code — OAP, “Lamp, Non-Heating, For Hair Growth” — which currently holds 112 clearances. That makes this category unusually checkable: the register is closed, so a brand either appears in it or it does not.

Below is every consumer cap we track, matched to the K-number actually on file. Every K-number, holder name, device name and date is copied verbatim from the FDA's 510(k) API, pulled 2026-08-16 — none of it is taken from a brand's marketing page.

The record

What the two tiers mean

Brand-held (5). The clearance is filed under the name on the box. Kiierr, Capillus, Theradome, REVIAN and LG each hold their own K-number.

OEM or licensor-held (7). The clearance is real, but the holder is a manufacturer or parent company rather than the brand you buy. iRestore's paper is filed by Freedom Laser Therapy; HairMax's by Lexington International; Bosley's by PJM Worldwide d/b/a Phoenix Medical Technology; HigherDOSE's Red Light Hat by Shenzhen Kaiyan Medical Equipment — the same Chinese manufacturer that holds the clearance behind other brands in this list. None of that is improper. It is simply not what “FDA cleared” sounds like on the packaging.

Why these are not ranked

The masks on this site are ranked by independently measured irradiance — the mW/cm² a spectrometer actually recorded at the device surface. No equivalent measurement exists publicly for hair caps. We could rank them by advertised diode count instead, and most sites do, but this site says plainly that a marketing LED count never ranks a mask, and it will not rank a cap either. So these rows carry the record and no score. If independent measurement appears, they get ranked then.

What a clearance does and does not tell you

A 510(k) clearance is a safety-and-substantial-equivalence review, not a proof of results. It means the FDA agreed the device is comparable to one already on the market and is safe for its stated use. It is not a finding that the device will regrow your hair, and it is not FDA approval — a stricter, separate pathway these devices do not go through. The three phrases, decoded.

We test nothing, we sell nothing, and we give no medical advice. Hair loss has causes a lamp cannot address; a clinician is the right first stop. Links to retailers are affiliate links and never change a row's tier — a device is listed on its paperwork, not on whether it is buyable.

LED Mask Score indexes manufacturers' FDA marketing claims against the FDA's own public record — the 510(k) database and the registration & listing index — with links, so you can read the paper yourself. We test nothing and give no medical or skincare advice. A 510(k) clearance is a safety-and-equivalence review, not a performance ranking, an endorsement, or an "FDA approval." If a brand publishes a K-number or listing that changes a row, the page changes — the record wins.