Identity
- Trade Name
- 25GA ADJUSTABLE CHANDELIER ILLUMINATOR EUDAMEDBausch + Lomb FDA UDI
- Generic Name
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
- Device Name
- 25GA ADJUSTABLE CHANDELIER ILLUMINATOR EUDAMEDCHANDELIER ILL PROBE,25GA,5/BX FDA UDI
- Model / Reference
- BL5235 EUDAMEDFDA UDI
- Description
- CHANDELIER ILL PROBE,25GA,5/BX FDA UDI
Identifiers
- Catalog Number
- BL5235 FDA UDI
- Primary DI / UDI-DI
- 10757770524416 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10757770524416 EUDAMED
- 510(k) Number
- K151604 FDA UDI
- FDA Product Code
- MPA FDA UDI
- EMDN Code
- Q021108 OPHTHALMIC SURGERY PROBES, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Ophthalmic fibreoptic light instrument, single-use
Bausch + Lomb by Bausch & Lomb Incorporated — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic fibreoptic light instrument, single-use.
- Synergetics — SYNERGETICS USA, INC. · Class II
- Disposable Chandelier fiber (one fiber) with Photon connector and guidance needl — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- VitreQ — Vitreq B.V. · Class II
- 20ga Curved Laser Probe, Quantel — KATALYST SURGICAL, LLC · Class II
- 27ga Stiff MultiFlex Extendable Laser Probe, Quantel Connector — KATALYST SURGICAL, LLC · Class II
- 27ga Stiff MultiFlex Laser Probe, Alcon Connector — KATALYST SURGICAL, LLC · Class II
- Synergetics — SYNERGETICS USA, INC. · Class II
- VitreQ — Vitreq B.V. · Class II
Cleared under the same submission
K151604 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch & Lomb Incorporated
Sources (2)
- FDA UDI 7dfb37c8-b8d2-4cd5-a146-8e43a4e80dac 35 fields · synced Oct 8, 2026
- EUDAMED d62b3e84-5762-415d-a5f7-f85399c6e5c3 61 fields · synced Oct 8, 2026