Identity
- Trade Name
- SANO FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types. There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. FDA UDI
- Model / Reference
- P-808, P-808L, P-808S, P-808W FDA UDI
- Description
- The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types. There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973511890009 FDA UDI
- 510(k) Number
- K191970 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological diode 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 diode laser system
Sano by Beijing Sano Lasers S&T Development Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological diode laser system.
- Emerge Handpiece — Cynosure, LLC · Class II
- GSD — Shenzhen GSD Tech Co., Ltd. · Class II
- VIKINI Laser H/P — ILOODA.CO., LTD · Class II
- HAIR REMOVAL LASER — TRIA LASER INC · Class II
- HAIR REMOVAL LASER — TRIA LASER INC · Class II
- Diode Laser Therapy Machine — Beijing ADSS Development Co., Ltd. · Class II
- DioBreeze — FORMATK SYSTEMS LTD · Class II
- TwinScan 808/755 Laser System — GME German Medical Engineering GmbH · Class II
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 af49ccf3-45fc-4c47-a485-1d1b12ecac9a 34 fields · synced May 30, 2026