Laser cap, comb or helmet
Last checked 2026-10-02.
A helmet or cap covers the scalp while you do something else; a comb is moved section by section by hand. Of the 5 devices here, 4 are helmets and 1 is a comb, the HairMax LaserComb Ultima 12 Classic, and it is the only one whose own 510(k) cites randomized, double-blind trials. All carry the same cleared indication; sessions run from 8 to 25 minutes, on different schedules.
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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Five devices, by form
| Essential | Professional | Elite | Theradome PRO | HairMax Ultima 12 | |
|---|---|---|---|---|---|
| Form | Helmet or cap | Helmet or cap | Helmet or cap | Helmet or cap | Comb |
| Hands-free | yes | yes | yes | yes | no: moved across the scalp by hand |
| 510(k) | K213094 “ID-500 iRestore Hair Growth System”, held by Freedom Laser Therapy, Inc., decided 2021-12-22 (summary) | K183417 “iRestore Professional 282”, held by Freedom Laser Therapy, Inc., decided 2019-05-17 (summary) | K222081 “ID-510 iRestore Elite”, held by Freedom Laser Therapy, Inc., decided 2022-10-13 (summary) | K171775 “Theradome LH80 PRO”, held by Theradome, Inc., decided 2018-01-09 (summary) | 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”) |
| Clinical data in its own 510(k) | No: cleared as substantially equivalent to predicate devices, with non-clinical tests only | No: cleared as similar to the earlier iRestore Hair Growth System (K151662), without its own clinical data | No: cleared as substantially equivalent to predicate devices, with non-clinical tests only | No: its 510(k) summary says “Brief Description of Clinical Testing: Not applicable” | Yes: K103368 cites two randomized, double-blind, controlled multi-center trials in men; K111714 cites one in women |
| Light sources | 120 lasers and LEDs (iRestore's count); the summary gives 655 nm, laser and LED | 82 lasers and 200 LEDs (510(k) summary) | 300 lasers and 200 LEDs (510(k) summary) | 80 lasers, no LEDs (510(k) summary) | 12 lasers, no LEDs (hairmax.com) |
| Session | 25 minutes; schedule not stated in the sources read | 25 minutes, every other day, for 16 weeks (510(k) summary); the Amazon listing says 2 to 3 times a week | 12 minutes, daily (510(k) summary and Amazon listing) | 20 minutes, twice a week (theradome.com) | 8 minutes, 3 days a week (hairmax.com) |
| Power | AC powered (510(k) summary) | plugged in; a battery pack is sold separately (Amazon listing) | not stated in the sources read | rechargeable and wireless (theradome.com) | cordless, rechargeable (hairmax.com) |
| Warranty | not stated in the sources read | not stated in the sources read | not stated in the sources read | 1 year (theradome.com) | 1 year (hairmax.com) |
| Sources | iRestore's device list, irestorelaser.com; Amazon listing (session length) | iRestore's device list, irestorelaser.com; Amazon listing | iRestore's device list, irestorelaser.com; Amazon listing | Theradome PRO LH80 page, theradome.com | Ultima 12 LaserComb page, hairmax.com; FDA registration and listing (ties Ultima 12 Classic to K103368 and K111714) |
| Buy | Amazon → | Amazon → | Amazon → | Amazon → | Amazon → |
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.
Choosing a form
Coverage and effort differ, not the clearance: every device here is cleared for the same pattern hair loss, and the same skin phototypes. A comb needs the hair parted as it moves, per its maker; a helmet or cap runs on a timer. Which schedule you can keep matters because the trials below ran for months.
For caps from brands not compared here, LEDMaskScore's record of laser-cap clearances lists each consumer cap's 510(k) number, holder and year cleared under product code OAP.
The three iRestore helmets in detail: iRestore Essential vs Elite vs Professional. Whether any of this works: what the trials show.
We tested nothing. This page gives no medical advice and makes no promise of results.