Apolomed

GUDID 06970745912309

Fiber Laser Treatment System

Shanghai Apolo Medical Technology Co., Ltd.

Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system

• Primary Device ID: 06970745912309
• NIH Device Record Key: 1d516fc5-eca2-4575-8f63-1fa1f2fef299
• Commercial Distribution Discontinuation: 2027-11-29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apolomed
• Version Model Number: HS-230
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970745912309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221770

FDA Product Code

• ONG: Powered Laser Surgical Instrument With Microbeam\Fractional Output

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: 2022-12-08
• Device Publish Date: 2022-11-30

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