DeviceClearance

Product code OAP— Physical Medicine

HAIRMAX LASERCOMB

Classification name
Laser, Comb, Hair
Device class
Class 2
Regulation
21 CFR 890.5500
Advisory panel
Physical Medicine
Total cleared
112
First cleared
Most recent

FDA classification definition

“Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v”

— U.S. Food and Drug Administration, device classification record for product code OAP under 21 CFR 890.5500, via openFDA

Market context for product code OAP

FDA has cleared 112 devices under product code OAP between 2007 and 2026, filed by 59 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OAP

Recent clearances under product code OAP

1–100 of 112

Data sourced from openFDA. This site is unofficial and independent of the FDA.