CurrentBody Skin™

GUDID 00655729008235

The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Cosmetic red-light phototherapy system, home-use
Primary Device ID00655729008235
NIH Device Record Keyb1a814ea-0ec9-43cd-912c-d8277d0ed65e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCurrentBody Skin™
Version Model NumberMK66R-B
Company DUNS543062382
Company NameShenzhen Kaiyan Medical Equipment Co,. Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100655729008235 [Primary]

FDA Product Code

OHSLight Based Over The Counter Wrinkle Reduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-10-21
Device Publish Date2024-01-30

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