Light Based Over-the-counter Hair Removal

Product Code: OHT

General & Plastic Surgery Medical Laser Products

Definition: Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal.

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

Code of Federal Regulations: 878.4810


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as OHT

5800Light Based Over-the-counter Hair RemovalLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

5800Light Based Over-the-counter Hair RemovalLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

Light Based Over-The-Counter Hair Removal [30278]21 CFR §878.4810 🔎
Light Based Over-The-Counter Hair Removal [38651]21 CFR §878.4810 🔎
Light Based Over-The-Counter Hair Removal [38649]21 CFR §878.4810 🔎
Light Based Over-The-Counter Hair Removal [38650]21 CFR §878.4810 🔎
Light Based Over-The-Counter Hair Removal [34006]21 CFR §878.4810 🔎

Pre-market Notifications for OHT

K222710IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd.
K222598IPL Hair Removal DeviceShenzhen Noble Smart Manufacturing Tech Co. Ltd
K222537IPL Hair Removal Device, Model(s): Skn001,skn005,skn006,skn002,RoseSkinCo LumiShenzhen Ishine Technology Company Limited
K222432IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439Hunan Guangye Biotechnology Co., Ltd.
K222316IPL Hair Removal DeviceShenzhen Goodwind Technology Development CO., LTD
K221679IPL Hair Remover, Model: G993, G996, G998 And G885Shenzhen Mywin Technology Co., Ltd.
K221635IPL Sapphire Ice Cooling Hair Remove DeviceShenzhen Desida Technology Co., Ltd.
K221643Hair Removal Device (Model: IPL-D26, IPL-D19)Shenzhen Desida Technology Co., Ltd.
K221553Diamond Air+ (UI04A, UI04B, UI04C)Ulike Co., Ltd
K221569Intense Pulsed Light (IPL) System, Model: T013C, T015C, T015KShenzhen Fansizhe Science And Technology Co., Ltd
K221466IPL Hair Removal Device, Model: AI01, AI06, AI08, AI16, AI17Shenzhen Century Dongyuan Technology Co Ltd.
K221246IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)Shenzhen Semlamp Intelligent Technology Co., Ltd
K221001IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co.,Ltd.
K221002IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co.,Ltd
K220927IPL Hair RemovalShenzhen Qiaochengli Technology Co., Ltd.

Global Unique Device Identification Database

00074108368751Light Based Over-The-Counter Hair Removal
00069055886199Light Based Over-The-Counter Hair Removal
10069055882426Light based over-the-counter hair removal
10069055880958Light based over-the-counter hair removal
10069055879815Light based over-the-counter hair removal
10069055879808Light based over-the-counter hair removal
10069055879648Light based over-the-counter hair removal
10069055879068Light based over-the-counter hair removal
10069055876586Light based over-the-counter hair removal
10069055876579Light based over-the-counter hair removal
10852547004730Light Based Over-The-Counter Hair Removal
10852547004495Light Based Over-The-Counter Hair Removal
06971648210011Light Based Over-The-Counter Hair Removal
16970821120052Light Based Over-The-Counter Hair Removal
06970821120031Light Based Over-The-Counter Hair Removal

Maude Adverse Events

DEES DEESS GP586 PERMANENT HAIR REMOVAL DEVICE, 350,000 FLASHES HOME USE, IPL HASHENZHEN GSD TECH CO., LTD2019-07-29
BOSIDIN FACIAL & BODY PERMANENT HAIR REMOVAL FOR WOMENBOSIDI TECHNOLOGY, CO., LTD.2019-03-29
LASER HAIR REMOVALUNK2016-12-22
PHILIPS LUMEA COMFORTPHILIPS MEDICAL SYSTEMS INTERNATIONAL BV2016-05-05
BELLAFLASH BY SILK'N LASERHOMESKINOVATIONS2015-12-29

© 2023 FDA.report
This site is not affiliated with or endorsed by the FDA.