Identity
- Trade Name
- Smart532 TM EUDAMEDSmart532 FDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Model / Reference
- NA EUDAMEDFDA UDIGA-1005557Be EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810096330062 EUDAMEDFDA UDI
- Basic UDI-DI
- 081009633PCABF EUDAMED
- 510(k) Number
- K151109 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Ophthalmic solid-state 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
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
GA-1005557Be by Lumenis Be, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081009633PCABF | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Lumenis Be Inc
- EUDAMED SRN
- US-MF-000016037
- Authorised Representative
- Lumenis (Germany) GmbH DE-AR-000007699
Sources (3)
- EUDAMED 68301fbf-a724-4db2-9394-1e463bc9033d 61 fields · synced Jul 23, 2026
- FDA UDI bbad9528-6a0b-4a7a-97d2-05cf2e523a26 33 fields · synced May 30, 2026
- EUDAMED 9b3e972d-8eb8-4a5a-abb4-e5da09cf840c 61 fields · synced Jul 23, 2026