Manufacturer
Beijing Sano Laser S&T Development Co.,LtdCryojet 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
Product code
GEX
21 CFR 878.4810
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
1K233416 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K233416 as a predicate
