Lucent IPL

GUDID 00754016214004

Luvo Medical Technologies Inc

Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable
Primary Device ID00754016214004
NIH Device Record Key16ec24dc-551f-47cf-9613-8123bf3e5c72
Commercial Distribution StatusIn Commercial Distribution
Brand NameLucent IPL
Version Model NumberESM-9200IL
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
GS100754016214004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-09
Device Publish Date2021-06-01

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

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