Identity
- Trade Name
- SANO FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SHE-LSP003-1 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973511890108 FDA UDI
- 510(k) Number
- K242941 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological carbon dioxide laser system
Sano by Beijing Sano Lasers S&T Development Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Beijing Sano Lasers S&T Development Co., Ltd.
Sources (1)
- FDA UDI 2e49c95d-1ae0-4b69-b961-be9088a70d62 34 fields · synced May 30, 2026