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Diode Laser Therapy Devices
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 8110Model HS-811N
Identity
- Trade Name
- Diode Laser Therapy Devices EUDAMEDApolomed FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- Diode Laser Therapy Devices EUDAMEDDiode Laser Therapy Device FDA UDI
- Model / Reference
- HS-811N EUDAMEDFDA UDI8110 EUDAMED
- Description
- Diode Laser Therapy Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970745918110 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970745918110 EUDAMED
- 510(k) Number
- K200118 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
- GMDN Term
- Dermatological diode laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Diode Laser Therapy Devices by Shanghai Apolo Medical Technology Co., Ltd — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200118 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06970745918110 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shanghai Apolo Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000002904
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED f58dddea-f3b1-44d6-963f-6241968f9cce 61 fields · synced Oct 6, 2026
- FDA UDI 30138aa1-fa2d-4fe0-b90c-e095fd596259 35 fields · synced May 30, 2026
- FDA 510(k) K200118 1 fields · synced May 18, 2026