Identity
- Trade Name
- Diode Laser Therapy Machine FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Model / Reference
- FG 2000-D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970453270098 FDA UDI
- 510(k) Number
- K161692 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological diode laser system
Diode Laser Therapy Machine by Beijing ADSS 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
- DioBreeze — FORMATK SYSTEMS LTD · Class II
- TwinScan 808/755 Laser System — GME German Medical Engineering GmbH · Class II
- Darwin RF Thermal — Luvo Medical Technologies Inc · Class II
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing ADSS Development Co., Ltd.
Sources (1)
- FDA UDI bd2e591a-8b58-4172-8dc3-b35abb9086eb 33 fields · synced May 31, 2026