VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
FDA 510(k) clearance K050623 · decided 2005-03-28
Clearance details
- K-number
- K050623
- Device name
- VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
- Applicant
- Volk Optical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-10
- Decision date
- 2005-03-28
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- HJK
- Device class
- 2
- Regulation number
- 886.1385
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying recall (Z-1244-2026) | Vortex Surgical Inc. | 2026-02-04 |