Apolomed

GUDID 06970745914129

CO2 Laser Therapy System

Shanghai Apolo Medical Technology Co., Ltd.

General/multiple surgical carbon dioxide laser system

• Primary Device ID: 06970745914129
• NIH Device Record Key: 935d58fd-08c8-4126-b555-5ef9fee1d379
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apolomed
• Version Model Number: HS-411A
• Company DUNS: 529854247
• Company Name: Shanghai Apolo Medical Technology 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970745914129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201109

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: 2020-07-30
• Device Publish Date: 2020-07-22

On-Brand Devices [Apolomed]

• 06970745918905: Diode Laser Therapy Devices
• 06970745917700: Phototherapy Systems
• 06970745916505: IPL (Intense Pulsed Light) Treatment Systems
• 06970745913009: IPL(Intense Pulsed Light) Treatment Systems
• 06970745912910: EO Q-Switched Nd:YAG Laser Systems
• 06970745912903: EO Q-Switched Nd: YAG Laser Systems
• 06970745918196: Diode Laser Therapy Device
• 06970745918189: Diode Laser Therapy Device
• 06970745918172: Diode Laser Therapy Device
• 06970745918165: Diode Laser Therapy Device
• 06970745918127: Diode Laser Therapy Device
• 06970745918110: Diode Laser Therapy Device
• 06970745918103: Diode Laser Therapy Device
• 06970745916604: IPL (Intense Pulsed Light) Treatment Systems
• 06970745916512: IPL (Intense Pulsed Light) Treatment Systems
• 06970745916208: IPL (Intense Pulsed Light) Treatment Systems
• 06970745913108: IPL (Intense Pulsed Light) Treatment Systems
• 06970745913016: IPL (Intense Pulsed Light) Treatment Systems
• 06970745912989: Picosecond Nd: YAG Laser System
• 06970745914129: CO2 Laser Therapy System
• 06970745914112: CO2 Laser Therapy System
• 06970745918516: Diode Laser Body Sculpture System
• 06970745919001: Platform Treatment System
• 06970745912309: Fiber Laser Treatment System
• 06970745915911: Electromagnetic Stimulation Systems