BENIONE

GUDID 06975526410005

Shenzhen Noble Smart Manufacturing Tech. Co., Ltd.

Intense pulsed light skin surface treatment system
Primary Device ID06975526410005
NIH Device Record Key607ae2a3-f662-45fd-926a-324b91cd0869
Commercial Distribution StatusIn Commercial Distribution
Brand NameBENIONE
Version Model NumberM052W1101
Company DUNS550670270
Company NameShenzhen Noble Smart Manufacturing Tech. 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 Numberfalse
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
GS106975526410005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OHTLight Based Over-The-Counter Hair Removal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-01-18
Device Publish Date2023-01-10

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