Phototherapy Unit

GUDID 08809578390030

IDS Ltd

Intense pulsed light skin surface treatment system
Primary Device ID08809578390030
NIH Device Record Key06285fcf-270b-476a-a485-107359b027fa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhototherapy Unit
Version Model NumberSHINY RPL SYSTEM
Company DUNS689046045
Company NameIDS 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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809578390030 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-10-19
Device Publish Date2018-12-31

Devices Manufactured by IDS Ltd

08809578390313 - Picosecond Nd:YAG Laser2024-01-05
08809578390344 - Alexandrite & Long Pulsed Nd:YAG Laser2023-04-17
08809578390030 - Phototherapy Unit2021-10-19
08809578390030 - Phototherapy Unit2021-10-19
08809578390016 - Q-Switched Nd:YAG Laser2019-06-11

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