Darwin IPL Handpiece

GUDID 00754016214158

Luvo Medical Technologies Inc

Dermatological diode laser system
Primary Device ID00754016214158
NIH Device Record Key5d8b20b4-ee28-4dd4-b95e-7972d07fc76b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDarwin IPL Handpiece
Version Model Number3134 A9999001LV
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
GS100754016214158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-10-24
Device Publish Date2022-10-14

Devices Manufactured by Luvo Medical Technologies Inc

00754016214134 - Darwin 2022-10-24
00754016214158 - Darwin IPL Handpiece2022-10-24
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

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