Cryojet Plus (SHE-ACP001-1)

Beijing Sano Laser S&T Development Co.,Ltd

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K233416
Device name
Cryojet Plus (SHE-ACP001-1)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-10-10
Decision date
2024-02-06
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Skin tightening
Primary application
Skin tightening
Classification source
AI classified

Indications for Use

Cryojet Plus is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

Intended Use

Cryojet Plus is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

Device Description

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. Software is used for system initialization, displaying user interface and cooling system control. Parameter setting (therapy time and wind level) can be done by touching LCD screen, thus START/STOP and defrosting of device can be controlled. The software can be used in conjunction with hardware system during treatment to minimize thermal damage to tissues and reduce pain.

Summary parsed at:2026-06-01 05:26:58 UTC

Predicate devices

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