SANO
Basic Information
- Brand Name
- SANO
- Primary DI
- 06973511890078
- Version / Model
- SHE-ACP001-1
- Company Name
- Beijing Sano Lasers S&T Development Co., Ltd.
- Labeler DUNS
- 414243850
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-15
- Public Version
- 1
- Public Version Date
- 2024-05-23
- Public Version Status
- New
- Public Device Record Key
- 416107aa-8a01-4693-be6e-41feb250db3b
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36758 | Localized cutaneous/musculoskeletal cryotherapy unit | An electrically-powered unit intended to create a stream of cold air/vapour (e.g., liquid nitrogen) for application to the skin surface for various localized therapeutic applications such as relief of underlying musculoskeletal symptoms (e.g., pain, spasm, inflammation, bruising), reduction of dermal pain/inflammation, and/or reduction of thermal skin damage during dermatological laser treatments. In addition to the main unit it may include a hose and spray-producing nozzle. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973511890078 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233416 | 000 |