DR.NAOMI

GUDID 00794712393542

The LED Light Therapy Mask (Models: MK-78)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

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Primary Device ID00794712393542
NIH Device Record Key1a07258d-ff30-463d-83d6-72b05bc7a8e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDR.NAOMI
Version Model NumberMK-78
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
GS100794712393542 [Primary]

FDA Product Code

OHSLight Based Over The Counter Wrinkle Reduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-08
Device Publish Date2024-01-31

Devices Manufactured by Shenzhen Kaiyan Medical Equipment Co,. Ltd

09331923700472 - Ellodi2024-02-09 The LED Light Therapy Mask (Models: EL00003) is an over the counter device intended to emit energy in the red and blue region of
00794712393542 - DR.NAOMI2024-02-08The LED Light Therapy Mask (Models: MK-78)is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
00794712393542 - DR.NAOMI2024-02-08 The LED Light Therapy Mask (Models: MK-78)is an over the counter device that is intended for the use in the treatment of full-fa
00655729008266 - CurrentBody Skin™2024-02-07 The LED Eye Perfector (Model: EY-36A) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the perio
00655729008426 - CurrentBody Skin™2024-02-07 The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fine lines and wrinkles and increase
00731093153136 - CurrentBody Skin™2024-02-07 The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in male
00850035134368 - Solawave 2024-02-07 The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-cou
00850035134887 - Solawave 2024-02-07 The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-coun
05060282690288 - LUSTRE2024-02-07 The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of

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