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LaseMD Ultra Laser System main body (Including Fiber and Handpiece)
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref LaseMD Ultra
Identity
- Trade Name
- LaseMD Ultra Laser System main body (Including Fiber and Handpiece) EUDAMED
- Device Name
- Thulium laser EUDAMED
- Model / Reference
- LaseMD Ultra EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809447656090 EUDAMED
- Basic UDI-DI
- 88094476511202AVS EUDAMED
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
LaseMD Ultra Laser System main body (Including Fiber and Handpiece) by Lutronic Corporation — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171009 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 88094476511202AVS | Class IIb | Active |
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Manufacturer
- Manufacturer
- Lutronic Corporation
- EUDAMED SRN
- KR-MF-000009035
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3ee7dbf2-e036-49cc-87d1-1497ec1fe51a 61 fields · synced Jul 9, 2026
- FDA 510(k) K171009 1 fields · synced May 18, 2026