Identity
- Trade Name
- 27ga Curved Laser Probe - Iridex Compatible FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- 27ga Curved Laser Probe - Iridex Compatible FDA UDI
- Model / Reference
- VS0120.27I FDA UDI
- Description
- 27ga Curved Laser Probe - Iridex Compatible FDA UDI
Identifiers
- Catalog Number
- VS0120.27I FDA UDI
- Primary DI / UDI-DI
- B384VS012027I1 FDA UDI
- 510(k) Number
- K021696 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Ophthalmic laser system beam guide 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 27 Gauge FDA UDI
Category: Ophthalmic laser system beam guide
27ga Curved Laser Probe - Iridex Compatible by Vortex Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- OtoProbe™ Long Angled Single — Iridex Corporation · Class II
- Synergetics — SYNERGETICS USA, INC. · Class II
- OtoProbe™ Short Angled Box of 6 — Iridex Corporation · Class II
Cleared under the same submission
K021696 also covers:
- 23ga Flexible Tapered Laser Probe - Alcon Compatible — Vortex Surgical, Inc.
- 23ga Flexible Tapered Laser Probe - Iridex Compatible — Vortex Surgical, Inc.
- 23ga Straight Laser Probe - Alcon Compatible — Vortex Surgical, Inc.
- 25ga Curved Laser Probe - Alcon Compatible — Vortex Surgical, Inc.
- 25ga Flexible Tapered Laser Probe - Iridex Compatible — Vortex Surgical, Inc.
- 25ga Straight Laser Probe - Alcon Compatible — Vortex Surgical, Inc.
- 27ga Curved Laser Probe - Alcon Compatible — Vortex Surgical, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vortex Surgical, Inc.
Sources (1)
- FDA UDI 7229cd06-1f05-41b5-873d-b1b83a203dbd 37 fields · synced May 30, 2026