Omni Laser

GUDID 16976855557505

The Painless IPL System - KDT750 is a multi-wavelength non-invasive system for IPL skin treatments, treatment of vascular and pigmented lesions, and hair removal using multiple filters reflecting a wavelength range of 530nm to 950nm. The Painless IPL System consists of a system console, electronics and software, cooling system, and two hand pieces with different wavelength.

Shanghai Omni Laser Skinology Co., Ltd.

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Primary Device ID16976855557505
NIH Device Record Keyed88abc4-9fff-442c-a5f7-5083900fd7ad
Commercial Distribution Discontinuation2024-01-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOmni Laser
Version Model NumberKDT750
Company DUNS560463241
Company NameShanghai Omni Laser Skinology 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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106976855557508 [Primary]
GS116976855557505 [Package]
Contains: 06976855557508
Package: box [1 Units]
Discontinued: 2023-10-16
Not in Commercial Distribution

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 Date2024-01-09
Device Publish Date2024-01-01

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