4 FDA records filed under this company name, from 2016 to 2022, in hair growth (OAP, 4).
The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.
Laser and LED hair-growth caps, helmets and combs (1 record says prescription use) (OAP, 4)
Not quoted here. The statement contains words we couldn't confirm (a typo, run-together words or a reading error), and we don't correct FDA's text. Read FDA's PDF, page 3.
“The iRestore Professional 282 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, males who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.”
Not quoted here. The statement's clinical classification text (such as Norwood-Hamilton or Ludwig-Savin ranges) doesn't read cleanly, so we don't quote it rather than guess at a correction. Read FDA's PDF, page 3.