Illuminated Stepped Laser Probe, Curved With tapered tip for use in combinatio
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Illuminated Stepped Laser Probe, Curved With tapered tip for use in combinatio FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Model / Reference
- 7510.DORC FDA UDI
Identifiers
- Catalog Number
- 7510.DORC FDA UDI
- Primary DI / UDI-DI
- 08717872016146 FDA UDI
- 510(k) Number
- K031023 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- Ophthalmic laser system beam guide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
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 laser system beam guide
Illuminated Stepped Laser Probe, a versatile and precise device for ophthalmic laser surgery, is designed to provide targeted and effective treatment of non-refractive conditions. With its curved tapered tip and fibreoptic cable, this probe allows for precise control and minimizes damage.
Similar devices
Also classified as Ophthalmic laser system beam guide.
- CURVED LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4 — FCI S A S FCI 20 22 · Class II
- Engauge — Alcon Laboratories, Inc. · Class II
- 25ga Stiff Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector — KATALYST SURGICAL, LLC · Class II
- Synergetics — SYNERGETICS USA, INC. · Class II
- 23-27G BriteLight™ Angled 45° EndoProbe® Box of 6 — Iridex Corporation · Class II
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- Synergetics — SYNERGETICS USA, INC. · Class II
- OtoProbe™ Short Angled Box of 6 — Iridex Corporation · Class II
Cleared under the same submission
K031023 also covers:
- Illuminated Laser Probe, Curved, 20G / 0.9 mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Illuminated Laser Probe, Curved, 20G / 0.9 mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Illuminated Laser Probe, Straight 20G / 0.9 mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Illuminated Stepped Laser Probe, Curved With tapered tip for use in combinatio — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 20GA Alcon Illuminating Laser Probe - Alcon — Peregrine Surgical, LLC.
- 20GA Alcon Illuminating Laser Probe - Iridex — Peregrine Surgical, LLC.
- 20GA Curved Alcon Illuminating Laser Probe - Alcon — Peregrine Surgical, LLC.
- 20GA Curved Alcon Illuminating Laser Probe - Iridex — Peregrine Surgical, LLC.
- 20GA Curved Illuminating Laser Probe - Alcon — Peregrine Surgical, LLC.
- 20GA Curved Illuminating Laser Probe - Iridex — Peregrine Surgical, LLC.
- 20GA Curved Illuminating Probe, SMA 905 — Peregrine Surgical, LLC.
- 20GA Curved Illuminating Probe, SMA905 — Peregrine Surgical, LLC.
Authorization Coverage (1 country)
Regulatory Authorizations
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
Sources (1)
- FDA UDI a5fb6a98-e02c-48ce-91db-b1bba94dc8f9 34 fields · synced Jul 30, 2026