Diode Laser Hair Removal

GUDID 06940481500047

Wuhan Lotuxs Technology Co.,Ltd.

Home-use laser epilator
Primary Device ID06940481500047
NIH Device Record Key8c228112-d1ea-4570-97c8-e6b509a80da7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiode Laser Hair Removal
Version Model NumberLHR-V4-810
Company DUNS421343727
Company NameWuhan Lotuxs Technology 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106940481500047 [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 Date2024-09-02
Device Publish Date2024-08-23

On-Brand Devices [Diode Laser Hair Removal ]

06940481500047LHR-V4-810
06940481500085LHR-V8S-810
06940481500078LHR-V8-810
06940481500061LHR-V4S-810
06940481500221LHR-V6S/B-1064
06940481500207LHR-V6S-1064

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