Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
FDA 510(k) clearance K220263 · decided 2022-11-03
Clearance details
- K-number
- K220263
- Device name
- Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
- Applicant
- Vortex Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-31
- Decision date
- 2022-11-03
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- HQB
- Device class
- 2
- Regulation number
- 886.4690
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chesterfield, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Ca recall (Z-1245-2026) | Vortex Surgical Inc. | 2026-02-04 |
| Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Ti recall (Z-1246-2026) | Vortex Surgical Inc. | 2026-02-04 |
| Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; recall (Z-1004-2026) | Vortex Surgical Inc. | 2025-12-30 |