Laser, Comb, Hair

Product Code: OAP

Physical Medicine Medical Laser Products

Definition: Promote Hair Growth In Males With Androgenic Alopecia And Norwood Hamilton Classification Of Iia To V.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 890.5500


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as OAP

5481Laser, Comb, HairInfrared Lamp.

Total Product Life Cycle (TPLC) Devices

5481Laser, Comb, HairInfrared Lamp.

Pre-market Notifications for OAP

K222477Hair Growth DeviceDongguan Lescolton Medical Equipment Co., Ltd
K222364Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)Xtrallux, LLC
K222081ID-510 IRestore EliteFreedom Laser Therapy, Inc.
K220543Auxo A300, A150 And APodAuxo Hair, LLC
K213789Intelligence LaserCombYibin Yingtong Intelligent Technology Co.,Ltd.
K213447LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.Shenzhen CosBeauty Technology Co., Ltd.
K213094ID-500 IRestore Hair Growth SystemFreedom Laser Therapy, Inc.
K213025Laser Hair Growth HelmetKam Yuen Plastic Products Ltd.
K213027Laser Hair Growth CombKam Yuen Plastic Products Ltd
K210169Hair Growth DeviceDongguan Lescolton Intelligent Electrical Appliance Co., Ltd
K200929Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd.
K200464LG Pra. L Derma LD Scalp CareLG Electronics, Inc.
K193667Shapiro MD Model Laser 272Conversion Labs, PR, LLC
K193008Tricoglam Home UseAdvihair S.R.L.
K192627Laser Hair Growth CapShang Fa Biotechnology Co.

Global Unique Device Identification Database

00864918000343Laser, Comb, Hair
20861134000106Laser, Comb, Hair
00859690003361Laser, Comb, Hair
00858830007191Laser, Comb, Hair
00856823006152Laser, Comb, Hair
00856823006145Laser, Comb, Hair
00856823006138Laser, Comb, Hair
00856823006008Laser, Comb, Hair
00853327006299Laser, Comb, Hair
00853327006220Laser, Comb, Hair
00853327006213Laser, Comb, Hair
00853327006206Laser, Comb, Hair
00853327006190Laser, Comb, Hair
00853327006183Laser, Comb, Hair
06971777450029Laser, Comb, Hair

Maude Adverse Events

2019-03-19
2019-03-11
REGROW MD HAIRMAX LASER 272LEXINGTON INTL, LLC2019-03-05
2019-03-04
2018-09-17
2017-03-09
I GROW HAIR GROWTH SYSTEMAPIRA SCIENCE2017-03-06
2016-12-08
CAPILLIUS 272 PRO HAIR REGROWTH LASER THERAPY CAPCAPILLUS2016-09-01
ULTIMA 9 HAIR GROWTHLEXINGTON INTERNATIONAL LLC2015-10-14
HAIRMAX LASER COMBLEXINGTON2015-08-05
HAIRMAXLEXINGTON INTL LLC2015-06-23
HAIRMAX LASER COMB2013-09-06
HAIRMAX LASER BRUSHLEXINGTON INTERNATIONAL, LLC2011-08-02
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