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Medical Nd:YAG Laser Therapy Systems
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref HM-YL900
Identity
- Trade Name
- Huamei FDA UDI
- Generic Name
- Multi-modality skin surface treatment system generator FDA UDI
- Device Name
- Medical Nd:YAG Laser Therapy Systems EUDAMED
- Model / Reference
- HM-YL900 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973512860612 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06973512860612 EUDAMED
- 510(k) Number
- K202758 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
- GMDN Term
- Multi-modality skin surface treatment system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Germany 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
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
Medical Nd:YAG Laser Therapy Systems by Shandong Huamei 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 | K202758 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06973512860612 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shandong Huamei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025482
- Authorised Representative
- Tech4beauty GmbH DE-AR-000024345
Sources (3)
- EUDAMED 4ea9f5e8-cbaf-45b9-9792-063a9e96ce05 61 fields · synced Jul 10, 2026
- FDA UDI 2dd63ef8-49dd-4b8e-a098-ce516302c6c9 33 fields · synced May 30, 2026
- FDA 510(k) K202758 1 fields · synced May 18, 2026