AccessGUDID - DEVICE: Omni Laser (06976855557508)

GUDID

Device Identifier (DI) Information

Brand Name: Omni Laser
Version or Model: KDT750
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Shanghai Omni Laser Skinology Co., Ltd.

Primary DI Number: 06976855557508
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 560463241 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58935	Intense pulsed light skin surface treatment system	A mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis) to treat multiple skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed88abc4-9fff-442c-a5f7-5083900fd7ad
Public Version Date: January 09, 2024
Public Version Number: 1
DI Record Publish Date: January 01, 2024