Identity
- Trade Name
- SANO FDA UDI
- Generic Name
- Dermatological frequency-doubled solid-state laser system FDA UDI
- Device Name
- The Q-Switched Nd:YAG Laser is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for for General Dermatology, Dermatologic and General Surgical Procedures as follows: 1064nm: -Tattoo removal dark ink: blue and black -Treatment of Benign Pigmented Lesions Nevus of ota 532nm: -Tattoo removal Light ink: red, sky blue and green. -Treatment of benign vascular lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of benign pigmented lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus. FDA UDI
- Model / Reference
- SHE-LSP101-1 FDA UDI
- Description
- The Q-Switched Nd:YAG Laser is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for for General Dermatology, Dermatologic and General Surgical Procedures as follows: 1064nm: -Tattoo removal dark ink: blue and black -Treatment of Benign Pigmented Lesions Nevus of ota 532nm: -Tattoo removal Light ink: red, sky blue and green. -Treatment of benign vascular lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of benign pigmented lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16973511890006 FDA UDI
- 510(k) Number
- K250936 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological frequency-doubled solid-state 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 frequency-doubled solid-state 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 aca5ecf8-958f-4631-bcb6-f214e0340127 34 fields · synced May 30, 2026