Identity
- Trade Name
- LightSheer® Quattro™ EUDAMEDFDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Model / Reference
- NA EUDAMEDGA-1140000Be EUDAMEDLightSheer® Quattro™ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290117770030 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011777LSUW EUDAMED
- 510(k) Number
- K170179 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
- GMDN Term
- Dermatological diode laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Belgium 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-1140000Be by Lumenis Be Ltd — 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 | 729011777LSUW | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Lumenis Be LTD
- EUDAMED SRN
- IL-MF-000022063
- Authorised Representative
- Lumenis (Germany) GmbH DE-AR-000007699
Sources (3)
- EUDAMED 07cace81-4b6d-434d-8f11-7480b446842f 61 fields · synced Jul 18, 2026
- FDA UDI 5ff1b966-7bc5-4635-b6a3-6bdad2a41078 33 fields · synced May 30, 2026
- EUDAMED d72c68ed-9753-4f13-a76d-62712525b1eb 61 fields · synced Jul 18, 2026