510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OAPClass II

Laser, Comb, Hair

21 CFR 890.5500 / Physical Medicine
FDA source (opens on fda.gov)

OAP is the FDA product code for Laser, Comb, Hair, a class II device type, regulated under 21 CFR 890.5500. FDA's definition for this code reads: "Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v". As of , FDA records hold 112 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OAP
Device name
Laser, Comb, Hair
FDA definition
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
114
Ingested recalls
1

Clearances, product code OAP

By decision year
114 clearances under product code OAP with a decision year between 2007 and 2026, 2018 the highest year at 15.
Show the numbers
510(k) clearances under FDA product code OAP by decision year
YearClearances
20071
20091
20101
20114
20122
20133
20143
20158
20168
20175
201815
20199
20209
20215
20228
20238
202410
20256
20268

Applicants with the most clearances

Product code OAP
Applicants holding the most 510(k) clearances under product code OAP
ApplicantClearances
Capillus, LLC8
Lexington International, LLC8
Shenzhen Kaiyan Medical Equipment Co., Ltd5
Theradome, Inc.5
WONTECH Co., Ltd.5
Apira Science, Inc.4
Freedom Laser Therapy Inc4
Hubei Yjt Technology Co.,Ltd3
Light Tree Ventures Europe B.V.3
Nutra Luxe MD, LLC3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 74 companies shown, in name order