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Fiber Laser Treatment Systems
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 2309Model HS-230510(k) K221770Ref 2316Model HS-231
Identity
- Trade Name
- Fiber Laser Treatment Systems EUDAMEDApolomed FDA UDI
- Generic Name
- Dermatological dye laser system FDA UDI
- Device Name
- Dermatological Dye Laser Systems EUDAMEDFiber Laser Treatment System FDA UDI
- Model / Reference
- HS-230 EUDAMEDFDA UDI2309 EUDAMEDHS-231 EUDAMED2316 EUDAMED
- Description
- Fiber Laser Treatment System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970745912309 EUDAMEDFDA UDI06970745912316 EUDAMED
- Basic UDI-DI
- B-06970745912309 EUDAMEDB-06970745912316 EUDAMED
- 510(k) Number
- K221770 FDA UDI
- FDA Product Code
- ONG FDA UDI
- EMDN Code
- Z12011007 DYE SURGICAL LASER EUDAMED
- GMDN Term
- Dermatological dye laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Spain 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
Fiber Laser Treatment Systems 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 | K221770 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06970745912309 | 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 (4)
- EUDAMED a32a005c-b3de-476f-a39e-3196175cc8d9 85 fields · synced Oct 6, 2026
- EUDAMED a8236406-d1a8-4e52-841e-6fe9a3dfd1e7 61 fields · synced May 18, 2026
- FDA UDI 1d516fc5-eca2-4575-8f63-1fa1f2fef299 36 fields · synced May 29, 2026
- FDA 510(k) K221770 1 fields · synced May 18, 2026