AccessGUDID - DEVICE: CO2 Laser Therapy Machine (06970453270128)

GUDID

Device Identifier (DI) Information

Brand Name: CO2 Laser Therapy Machine
Version or Model: FG 900-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Beijing ADSS Development Co., Ltd.

Primary DI Number: 06970453270128
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 529128739 *Terms of Use

Device Description: No description.

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):	No
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?
61473	Dermatological carbon dioxide laser system	A mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam, intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161925	000

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: 4e649a3b-46a9-4aa5-9e56-c16ab41785d1
Public Version Date: September 07, 2022
Public Version Number: 1
DI Record Publish Date: August 30, 2022