Do laser hair-growth devices work?
Last checked 2026-10-02.
Sham-controlled trials and two meta-analyses found a real but modest effect in pattern hair loss: about 18 more hairs per cm² than a sham device, after months of use, with the evidence strongest in men. Most clearances do not rest on trials of their own: of the 5 devices here, 4 were cleared as equivalent to an earlier device without clinical data, and 1 cites trials in its own 510(k).
What these devices are cleared for. The FDA cleared them (product code OAP, 21 CFR 890.5500) to promote hair growth in androgenetic alopecia (pattern hair loss): in men with Norwood-Hamilton classifications IIa to V, and in women with Ludwig-Savin classifications I to II (some clearances add frontal patterns), and for both only in Fitzpatrick skin phototypes I to IV, per the Indications for Use in each device's 510(k) summary. They are not cleared for other kinds of hair loss, such as alopecia areata, telogen effluvium or scarring alopecia; Fitzpatrick skin phototypes V and VI; hair loss beyond Norwood-Hamilton V or Ludwig-Savin II. A 510(k) clearance is a substantial-equivalence review, not FDA approval and not proof that a device works for you.
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What the trials found
These are studies of the kind of device, not of the models below, unless the study names one.
- Leavitt and others, 2009, Clinical Drug Investigation (PMID 19366270): HairMax LaserComb against a sham device, randomized and double-blind; 110 men completed it; terminal hair density rose significantly more with the comb at 26 weeks.
- Jimenez and others, 2014, American Journal of Clinical Dermatology (PMID 24474647): four sham-controlled lasercomb trials, 122 women and 103 men analysed; terminal hair counts rose by about 18 to 26 hairs per cm² with the comb against about 2 to 9 with the sham at 26 weeks.
- Lanzafame and others, 2013, Lasers in Surgery and Medicine (PMID 24078483): a 655 nm cap against a sham in men, 41 completed; about 35 to 39 percent more hair growth than the sham.
- Lanzafame and others, 2014, Lasers in Surgery and Medicine (PMID 25124964): the same kind of cap against a sham in women, 42 completed; about 37 percent more hair growth than the sham.
- Adil and Godwin, 2017, Journal of the American Academy of Dermatology (PMID 28396101): a meta-analysis: low-level laser therapy did better than placebo in men, with high heterogeneity between the studies.
- Alahmadi and others, 2026, Skin Appendage Disorders (PMID 42339398): a meta-analysis of 37 studies: about 18.6 more hairs per cm² than sham, and about 11.8 more when added to minoxidil.
Limits the studies themselves report: small trials, often run or funded by makers, high heterogeneity between studies, and results measured as hair counts in a marked scalp area over months. None of them tested skin phototypes V or VI, which is why no clearance covers them.
What each clearance rests on
| Device | 510(k) | Clinical data in its own 510(k) | |
|---|---|---|---|
| iRestore Essential | K213094 “ID-500 iRestore Hair Growth System”, held by Freedom Laser Therapy, Inc., decided 2021-12-22 (summary) | No: cleared as substantially equivalent to predicate devices, with non-clinical tests only | Amazon → |
| iRestore Professional | K183417 “iRestore Professional 282”, held by Freedom Laser Therapy, Inc., decided 2019-05-17 (summary) | No: cleared as similar to the earlier iRestore Hair Growth System (K151662), without its own clinical data | Amazon → |
| iRestore Elite | K222081 “ID-510 iRestore Elite”, held by Freedom Laser Therapy, Inc., decided 2022-10-13 (summary) | No: cleared as substantially equivalent to predicate devices, with non-clinical tests only | Amazon → |
| Theradome PRO LH80 | K171775 “Theradome LH80 PRO”, held by Theradome, Inc., decided 2018-01-09 (summary) | No: its 510(k) summary says “Brief Description of Clinical Testing: Not applicable” | Amazon → |
| HairMax LaserComb Ultima 12 Classic | K103368 “HairMax LaserComb Advanced 7, Lux 9 and Professional 12”, held by Lexington International, LLC, decided 2011-04-06 (summary); also K111714 (women, “HairMax Dual 12”) | Yes: K103368 cites two randomized, double-blind, controlled multi-center trials in men; K111714 cites one in women | Amazon → |
Whether a clearance is held by the brand on the box or by a manufacturer or licensor behind it is set out, cap by cap, in LEDMaskScore's record of laser-cap clearances under product code OAP.
Kinds of claim on this page: 510(k) numbers, holders, dates, indications and whether a clearance cites clinical data are product evidence from the FDA database; trial results are technology research about low-level laser devices in general, cited to each study, never evidence for one model; session times, schedules, power and warranty are manufacturer claims from each maker's page or the Amazon listing. All read 2026-10-02. Anything no source states is marked as not stated. No prices are shown: check the retailer for the current price.
By form and session: cap, comb or helmet. The iRestore models: Essential vs Elite vs Professional.
We tested nothing. This page gives no medical advice and makes no promise of results. Hair loss has causes these devices are not cleared to treat: a clinician can say which kind you have.