BARE: 808 HANDPIECE

GUDID 00754016214035

Luvo Medical Technologies Inc

Dermatological diode laser system
Primary Device ID00754016214035
NIH Device Record Key217032be-d8dd-439a-810b-f794db2ae373
Commercial Distribution StatusIn Commercial Distribution
Brand NameBARE: 808 HANDPIECE
Version Model Number9300-A0000101
Company DUNS204046564
Company NameLuvo Medical Technologies Inc
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100754016214035 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

Devices Manufactured by Luvo Medical Technologies Inc

00754016214134 - Darwin 2022-10-24
00754016214158 - Darwin IPL Handpiece2022-10-24
00754016214165 - Darwin Diode Laser Handpiece2022-10-24
00754016214172 - RF Microneedling Handpiece2022-10-24
00754016214189 - Darwin RF Thermal2022-10-24
00754016214127 - World PRP2021-08-19
00754016214028 - Bare 8082021-06-10
00754016214035 - BARE: 808 HANDPIECE 2021-06-10
00754016214035 - BARE: 808 HANDPIECE 2021-06-10

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