SANO

Primary DI
06973511890108
Brand
SANO
Company
Beijing Sano Lasers S&T Development Co., Ltd.
Model
SHE-LSP003-1
Device description
CO2 laser is monochromatic light with strong penetration and precise focusing; When a continuous laser beam with a certain energy irradiates biological tissue, the instantaneous high temperature causes photo induced solidification and photo induced vaporization to irradiated tissue. With modulation pulse mode of CO2 laser, treatment effect can be achieved by control of laser emission frequency. After choosing laser Power, despite the frequency of laser emission,the laser is continuously output at a fixed interval Time of 1 ms.Changes in frequency doesn't affect Interval Time. Such design is very effective for treating warts and moles. For cutting, it works in pulse mode, which causes lighter wound, and the heat-affected area looks much better than that of continuous working mode.
Published
2025-02-10
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
K242941000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242941000CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd2025-01-27GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973511890108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973511890108069735118901086973511890108

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological carbon dioxide laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam, intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch.

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
06973511890177SANOSHE-LSP601-32026-06-10
16973511890006SANOSHE-LSP101-12025-07-04
06973511890009SANOP-808, P-808L, P-808S, P-808W2024-05-15
06973511890061SANOSHE-MSP0022024-05-15
06973511890078SANOSHE-ACP001-12024-05-15
06973511890085SANOSHE-MSP0012024-05-15
06973511890092SANOSHE-MSP0032024-05-15

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Primary DI, Brand, Company table
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08800291820859PICOPLUSCynosure Lutronic Technology CorporationGEX2026-06-22
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