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MOSAIC 3D Laser System main body (Including Handpiece)
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref MOSAIC 3D
Identity
- Trade Name
- MOSAIC 3D Laser System main body (Including Handpiece) EUDAMED
- Device Name
- Er:Glass Laser EUDAMED
- Model / Reference
- MOSAIC 3D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809447656939 EUDAMED
- Basic UDI-DI
- 88094476510505AWD 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
MOSAIC 3D Laser System main body (Including 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
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 | K070392 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K080932 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 88094476510505AWD | 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 79660f88-585b-4ee9-ae06-3d0c690d202c 61 fields · synced Aug 4, 2026
- FDA 510(k) K070392 1 fields · synced May 18, 2026