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AC-2011950-OPTBe
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref AC-2011950-OPTBeModel NARef AC-20106870-OPTBe
Identity
- Trade Name
- OptiLight IPL Handpiece EUDAMEDFDA UDI
- Generic Name
- Intense pulsed light dry eye therapy unit FDA UDI
- Model / Reference
- NA EUDAMEDFDA UDIAC-2011950-OPTBe EUDAMEDAC-20106870-OPTBe EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290117771785 EUDAMEDFDA UDI07290117771914 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011777OPTHPJ2 EUDAMED
- FDA Product Code
- QIU FDA UDI
- EMDN Code
- Z12011019 MULTI–PLATFORM LASER EUDAMED
- GMDN Term
- Intense pulsed light dry eye therapy unit FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.5201 FDA UDI
- Market of Registration
- Bulgaria 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
AC-2011950-OPTBe 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 | 729011777OPTHPJ2 | 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 (6)
- EUDAMED 9a259cf0-cfd2-4224-87dd-1061abc010d4 61 fields · synced Jul 30, 2026
- EUDAMED 91be76ad-8f9d-4ae5-98f2-a577760f29d9 61 fields · synced May 17, 2026
- FDA UDI 80ccbef3-67da-4585-83ee-842dcf938f8d 32 fields · synced May 25, 2026
- FDA UDI 41bccce8-314c-4835-9624-10dbb362ed56 32 fields · synced May 30, 2026
- EUDAMED 54fdc050-f3a4-4941-a4e9-6f57d50ce4cf 61 fields · synced Jul 10, 2026
- EUDAMED 68e739b0-233d-4e52-ac6b-b21375b75ff7 61 fields · synced Jul 30, 2026