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LASEmaR 1500-L
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref LASEmaR 1500-LModel LASEmaR
by Eufoton Srl
Identity
- Trade Name
- LASEmaR 1500-L EUDAMED
- Device Name
- LASEmaR EUDAMED
- Model / Reference
- LASEmaR EUDAMEDLASEmaR 1500-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054188640963 EUDAMED
- Basic UDI-DI
- 805418864LASEMAR4GMB EUDAMED
- Direct Marketing DI
- 08054188640963 EUDAMED
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
LASEmaR 1500-L by Eufoton Srl — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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 | K260489 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 805418864LASEMAR4GMB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Eufoton Srl
- EUDAMED SRN
- IT-MF-000009227
Sources (2)
- EUDAMED e30439f3-3459-4cac-be6a-e9167eda3a34 61 fields · synced Jun 18, 2026
- FDA 510(k) K260489 1 fields · synced Jun 18, 2026