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Sano

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
SANO FDA UDI
Generic Name
Localized cutaneous/musculoskeletal cryotherapy unit FDA UDI
Device Name
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. FDA UDI
Model / Reference
SHE-ACP001-1 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
06973511890078 FDA UDI
510(k) Number
K233416 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Localized cutaneous/musculoskeletal cryotherapy unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Localized cutaneous/musculoskeletal cryotherapy unit

Sano by Beijing Sano Lasers S&T Development Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Localized cutaneous/musculoskeletal cryotherapy unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

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

Sources (1)

  • FDA UDI 416107aa-8a01-4693-be6e-41feb250db3b 34 fields · synced May 31, 2026