Light Based Over The Counter Wrinkle Reduction

Product Code: OHS

General & Plastic Surgery General Optical Products / Medical

Definition: Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4810


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as OHS

5799Light Based Over The Counter Wrinkle ReductionLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

5799Light Based Over The Counter Wrinkle ReductionLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

Light Based Over The Counter Wrinkle Reduction [30278]21 CFR §878.4810 🔎
Light Based Over The Counter Wrinkle Reduction [38651]21 CFR §878.4810 🔎
Light Based Over The Counter Wrinkle Reduction [38649]21 CFR §878.4810 🔎
Light Based Over The Counter Wrinkle Reduction [38650]21 CFR §878.4810 🔎
Light Based Over The Counter Wrinkle Reduction [34006]21 CFR §878.4810 🔎

Pre-market Notifications for OHS

K223278Easy ClaireY&J BIO Co., Ltd.
K222377Led Mask Platinum MdCellReturn Co., LTD.
K221444LED Eye Perfector, Model: EY-36A, EY-36BLight Tree Ventures Europe B.V.
K221430ReVive Light Therapy LED Cleansing SystemLED Technologies, Inc.
K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.
K220064Synergy Marble (Model: Opasm)YRS Group Inc
K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited
K213841ENEO TOTALE (Model: ENEOT947)Premier North America Inc.
K213285Easy ClaireY & J Bio Co., Ltd.
K213024Oren LED Perioral Light Therapy SystemShenzhen Kaiyan Medical Co Ltd
K212947Trinity Plus Wrinkle ReducerCarol Cole Company Dba NuFACE
K212771LightStim ElipsaLED Intellectual Properties LLC
K212275Dermalux Flex MDAesthetic Technology Ltd.
K210965ReVive Light Therapy EssentialsLED Technologies, Inc.
K210823LYMA LaserLYMA Life Ltd.

Global Unique Device Identification Database

00806248007562Light Based Over The Counter Wrinkle Reduction
00806248007463Light Based Over The Counter Wrinkle Reduction
00806248007425Light Based Over The Counter Wrinkle Reduction
00806248007296Light Based Over The Counter Wrinkle Reduction
00806248006459Light Based Over The Counter Wrinkle Reduction
10806248006333Light Based Over The Counter Wrinkle Reduction
10806248005329Light Based Over The Counter Wrinkle Reduction
00074108376619Light Based Over The Counter Wrinkle Reduction
00074108356918Light Based Over The Counter Wrinkle Reduction
00074108339065Light Based Over The Counter Wrinkle Reduction
00074108339058Light Based Over The Counter Wrinkle Reduction
00050428570289Light Based Over The Counter Wrinkle Reduction
00050428569931Light Based Over The Counter Wrinkle Reduction
00864918000374Light Based Over The Counter Wrinkle Reduction
00864918000312Light Based Over The Counter Wrinkle Reduction

Maude Adverse Events

BOOST ADVANCED LED LIGHT THERAPY FACE MASKTHE LIGHT SALON BOOST LIMITED2020-03-04
AVOLOGI ENEO ADVANCEDPREMIER NORTH AMERICA, INC.2019-09-10
DRX SPECTRALITE EYECARE PRO MASQUE LRDDR. DENNIS GROSS SKINCARE LLC2018-05-21
PERFECTIO PLUSZERO GRAVITY SKIN2017-01-21
EXPRESSIONENHANCEMENT MEDICAL2014-11-10
SYNERON EMAX MACHINE WITH SRA HEADSYNERON2012-01-21
DPL NUVE PAIN HANDHELD SYSTEMLED TECHNOLOGIES, LLC2011-05-17
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