Identity
- Trade Name
- Fixed Eye Safety Filter FDA UDI
- Generic Name
- Operator eye protection laser filter FDA UDI
- Model / Reference
- Fixed Eye Safety Filter 532/577/659 nm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810096330314 FDA UDI
- 510(k) Number
- K151109 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Operator eye protection laser filter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Operator eye protection laser filter
Fixed Eye Safety Filter by Lumenis Be, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Operator eye protection laser filter.
- Video Camera Insert — AMERICAN MEDICAL SYSTEMS, INC. · Class I
- PUREPOINT — Alcon Laboratories, Inc. · Class II
- Fixed Eye Safety Filter — Lumenis Be, Inc. · Class II
- Endo kit with Automatic Eye Safety Filter — Lumenis Be, Inc. · Class II
- Endo kit with Automatic Eye Safety Filter — Lumenis Be, Inc. · Class II
- Endo kit with Fixed Eye Safety Filter — Lumenis Be, Inc. · Class II
- Automatic Eye Safety Filter — Lumenis Be, Inc. · Class II
- Automatic Eye Safety Filter — Lumenis Be, Inc. · Class II
Cleared under the same submission
K151109 also covers:
- Array LaserLink — Lumenis Be, Inc.
- Automatic Eye Safety Filter — Lumenis Be, Inc.
- Automatic Eye Safety Filter — Lumenis Be, Inc.
- Endo kit with Automatic Eye Safety Filter — Lumenis Be, Inc.
- Endo kit with Automatic Eye Safety Filter — Lumenis Be, Inc.
- Endo kit with Fixed Eye Safety Filter — Lumenis Be, Inc.
- Endo kit with Fixed Eye Safety Filter — Lumenis Be, Inc.
- Fixed Eye Safety Filter — Lumenis Be, Inc.
- Laser Link HS — Lumenis Be, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lumenis Be, Inc.
Sources (1)
- FDA UDI 67566857-861a-46c3-988d-e06259a47629 33 fields · synced Jun 8, 2026