FDA-cleared laser caps for hair growth on Amazon
7 caps and helmets matched to their own 510(k) in the FDA database: the K-number, the lights its summary counts, and today's price, cheapest first. All are cleared to promote hair growth with androgenetic alopecia in men and women.
iRestoreEssential Laser Hair Growth System
$499
510(k) K213094, cleared for hair growth with androgenetic alopecia, men Norwood-Hamilton IIa to V and women Ludwig-Savin I to II.
Red-light helmet with diode lasers and LEDs, model ID-500, cleared in 2021 as the ID-500 iRestore Hair Growth System.. Sold by iRESTORE -.
iRestoreProfessional Laser Hair Growth System
$899
510(k) K183417, cleared for hair growth with androgenetic alopecia, men Norwood-Hamilton IIa to V and women Ludwig-Savin I to II.
Red-light helmet with 82 diode lasers and 200 red LEDs, as its 510(k) for the iRestore Professional 282 counts them.. Sold by iRESTORE -.
illumiflow272 Laser Cap
$899.99
510(k) K162071, cleared for hair growth with androgenetic alopecia, men Norwood-Hamilton IIa to V and women Ludwig-Savin I to II.
Cap with 272 red diodes at 650 nm. Sold by Illumiflow.
TheradomePRO LH80 Laser Hair Growth Helmet
$995
510(k) K171775, cleared for hair growth with androgenetic alopecia, men Norwood-Hamilton IIa to V and women Ludwig-Savin I to II.
All-laser helmet at 678 nm that turns itself off after a 20-minute session, cleared as the Theradome LH80 PRO.. Sold by Theradome Official Store.
CapillusPRO Laser Cap
$1100 $1699
510(k) K163170, cleared for hair growth with androgenetic alopecia, men Norwood-Hamilton IIa to V and women Ludwig-Savin I to II.
Soft cap with 272 diode lasers at 650 nm, the Capillus 272 Pro of its 510(k). Sold by Curallux.
HairmaxPowerFlex 272 Laser Cap
$1799
510(k) K180885, cleared for hair growth with androgenetic alopecia, men Norwood-Hamilton IIa to V and women Ludwig-Savin I to II.
Cap with 272 diode lasers, cleared as the HairMax Laser 272, used every other day.. Sold by Hairmax Official.
iRestoreElite Laser Hair Growth System
$1899
510(k) K222081, cleared for hair growth with androgenetic alopecia, men Norwood-Hamilton IIa to V and women Ludwig-Savin I to II.
Red-light helmet with 300 diode lasers and 200 superluminescent diodes, model ID-510, as its 510(k) counts them.. Sold by iRESTORE -.
Why no cap here has a dupe yet
For a device, a dupe on this site is one whose own 510(k) names the original as the device it is equivalent to, and costs at least 40% less. illumiflow's 272 cap names the Capillus 272 Pro, but costs about 18% less. Hubei YJT's helmets name both the Capillus 272 Pro and the iRestore Elite, under K253231, but on Amazon only a reseller sells them, and we don't link to resellers. The cheaper caps a brand does sell there either give no model number we could match or name other devices.
Questions
Which laser caps on Amazon are FDA-cleared?
7 that we matched to their own 510(k): iRestore Essential (K213094), iRestore Professional (K183417), illumiflow 272 Laser Cap (K162071), Theradome PRO LH80 (K171775), Capillus PRO (K163170), Hairmax PowerFlex 272 (K180885), iRestore Elite (K222081). Each is cleared to promote hair growth with androgenetic alopecia, in men at Norwood-Hamilton IIa to V and in women at Ludwig-Savin I to II.
What is the cheapest FDA-cleared laser cap on Amazon?
Of the caps we matched to a 510(k), the iRestore Essential, at $499 on Amazon today, cleared under K213094.
Is there a cheaper alternative to the iRestore Elite?
iRestore's own Essential, $499 against the Elite's $1899, cleared for the same use under K213094; the Elite has more light sources, 300 lasers and 200 diodes by its 510(k). No cheaper cap a brand sells on Amazon names the Elite as its equal: Hubei YJT's helmets do, under K253231, but only a reseller sells them there.
Do laser caps work for women?
They are cleared for both: every 510(k) here covers women with androgenetic alopecia at Ludwig-Savin I to II, and men at Norwood-Hamilton IIa to V, with skin types I to IV. Clearance means the FDA found each equivalent to a cap already sold for that use, not that it regrows hair for everyone.
How do I check whether a laser cap is FDA-cleared?
Search the FDA's 510(k) database by the brand or the model number on the listing. Caps under $100 on Amazon can say FDA-cleared with neither on the page; ask the seller for the K-number and look it up before you buy.