CO2 Laser Therapy Machine

GUDID 06970453270128

Beijing ADSS Development Co., Ltd.

Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system

Primary Device ID	06970453270128
NIH Device Record Key	4e649a3b-46a9-4aa5-9e56-c16ab41785d1
Commercial Distribution Status	In Commercial Distribution
Brand Name	CO2 Laser Therapy Machine
Version Model Number	FG 900-C
Company DUNS	529128739
Company Name	Beijing ADSS Development Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970453270128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K161925

FDA Product Code

GEX	Powered Laser Surgical Instrument

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-09-07
Device Publish Date	2022-08-30

On-Brand Devices [CO2 Laser Therapy Machine]

06970453270128	FG 900-C
06970453270111	FG 900-B
06970453270104	FG 900