VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D— 510(k) K050623

Name: FDA 510(k) clearance K050623
Creator: U.S. Food and Drug Administration
Published: 2005-03-28

Substantially Equivalent

Volk Optical, Inc.

FDA 510(k) clearance K050623 for VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D, Substantially Equivalent on 2005-03-28. Applicant: Volk Optical, Inc.. Device class: 2.

Clearance details

Applicant: Volk Optical, Inc.
Product code: Code HJK
Device class: Class 2
Regulation: 21 CFR 886.1385
Advisory panel: Ophthalmic
Date received: 2005-03-10
Decision date: 2005-03-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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K023221 — CONTACT LASER & DIAGNOSTIC LENSES2002-10-11
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Recalls naming K050623

K-number listed on FDA's recall record

Z-1244-2026 — Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMDClass II·Ongoing·Vortex Surgical Inc.·20251216

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050623.

Data sourced from openFDA. This site is unofficial and independent of the FDA.