Identity
- Trade Name
- Apolomed FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- Diode Laser Therapy Device FDA UDI
- Model / Reference
- HS-816 FDA UDI
- Description
- Diode Laser Therapy Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970745918165 FDA UDI
- 510(k) Number
- K200118 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
Yes
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
No
FDA UDI
Category: Dermatological diode laser system
Apolomed by Shanghai Apolo Medical Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
- Shanghai Apolo Medical Technology Co., Ltd
Sources (1)
- FDA UDI e5b50396-0fe5-4d9f-b9d3-de6228faf2d2 35 fields · synced Jun 8, 2026