← Back to catalogue
Medical Fractional CO2 Laser Therapy System
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref HM-CL200
Identity
- Trade Name
- Huamei FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- Medical Fractional CO2 Laser Therapy System EUDAMED
- Model / Reference
- HM-CL200 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973512860216 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06973512860216 EUDAMED
- 510(k) Number
- K192528 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
- GMDN Term
- Dermatological carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Poland 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 Fractional CO2 Laser Therapy System 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 | K192528 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06973512860216 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shandong Huamei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025482
- Authorised Representative
- Tech4beauty GmbH DE-AR-000024345
Sources (3)
- EUDAMED 5e97de8b-170a-4e28-8ca9-2c6df7433867 61 fields · synced Jul 24, 2026
- FDA UDI f6e43284-0699-4344-9f7f-61e8ff9ee6d9 33 fields · synced May 30, 2026
- FDA 510(k) K192528 1 fields · synced May 18, 2026