SANO

Primary DI
06973511890078
Brand
SANO
Company
Beijing Sano Lasers S&T Development Co., Ltd.
Model
SHE-ACP001-1
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.
Published
2024-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233416000Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd2024-02-06GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973511890078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973511890078069735118900786973511890078

GMDN Terms#

Term, Definition table
TermDefinition
Localized cutaneous/musculoskeletal cryotherapy unitAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
414243850
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16973511890006SANOSHE-LSP101-12025-07-04
06973511890108SANOSHE-LSP003-12025-02-10
06973511890009SANOP-808, P-808L, P-808S, P-808W2024-05-15
06973511890061SANOSHE-MSP0022024-05-15
06973511890085SANOSHE-MSP0012024-05-15
06973511890092SANOSHE-MSP0032024-05-15

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