SANO

GUDID 06973511890078

Cryojet Plus is intended to minimize pain and thermal injury during laser and dermatological treatments and for the temporary topical anesthetic relief for injections. And it shall be used by professionally trained medical operators. Cryojet Plus is composed of main body (including power supply system, control system, cooling system), power cable, supporting arm rod (a group of supporting rod, two support clips), wind tube, adapters, casters and other accessories. Control system consists of LCD screen display and control board, etc; Cooling system includes compressor, evaporator, radiator, fan, water tank; Power supply system is composed of power cable, filter and ON/OFF switch power. How It Works: Gaseous refrigerant is compressed into high-temperature and high-pressure gas by high-power compressor and sent to condenser for cooling. Refrigerant can produce cold air by condenser and evaporation system for skin cooling through conduction, evaporation and forced convection. Evaporator absorbs heat in air and vaporizes the heat, then heat is gaseous, then the gas is back to compressor and continue to be compressed. Thus cooling is done through such circulation. Defrosting system melts the frost inside evaporation system into liquid water and discharge the water through drain valve.

Beijing Sano Lasers S&T Development Co., Ltd.

Localized cutaneous/musculoskeletal cryotherapy unit

• Primary Device ID: 06973511890078
• NIH Device Record Key: 416107aa-8a01-4693-be6e-41feb250db3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SANO
• Version Model Number: SHE-ACP001-1
• Company DUNS: 414243850
• Company Name: Beijing Sano Lasers S&T 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: true
• 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	06973511890078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233416

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: 2024-05-23
• Device Publish Date: 2024-05-15

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