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Dermatological Diode Laser Systems
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref LD1, ALD1, ADPL2, DPL4510(k) K212478
Identity
- Trade Name
- Dermatological Diode Laser Systems EUDAMED
- Device Name
- Dermatological Diode Laser Systems EUDAMED
- Model / Reference
- LD1, ALD1, ADPL2, DPL4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 697669578LD1Z9 EUDAMED
- Basic UDI-DI
- B-697669578LD1Z9 EUDAMED
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Dermatological Diode Laser Systems by Beijing Stelle Laser Technology Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, 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 | K212478 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-697669578LD1Z9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing Stelle Laser Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038245
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED 77b7e6e1-e970-4d08-88fc-f8a2bffd2916 85 fields · synced Jun 18, 2026
- EUDAMED 77b7e6e1-e970-4d08-88fc-f8a2bffd2916-1 61 fields · synced Jun 10, 2026
- FDA 510(k) K212478 1 fields · synced May 18, 2026