CONTACT LASER & DIAGNOSTIC LENSES— 510(k) K023221

Name: FDA 510(k) clearance K023221
Creator: U.S. Food and Drug Administration
Published: 2002-10-11

Substantially Equivalent

Volk Optical, Inc.

FDA 510(k) clearance K023221 for CONTACT LASER & DIAGNOSTIC LENSES, Substantially Equivalent on 2002-10-11. 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: 2002-09-27
Decision date: 2002-10-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HJK

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K201909 — RxSight Contact Lens2020-09-10
K173944 — Endocular Viewing Lenses and Silicone Ring2018-10-25
K151961 — Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens2015-08-18
K142715 — Sensor Medical Family of Vitrectomy Lenses and Products2014-12-16
K051630 — SUPER VIEW DISPOSABLE BIOM LENS SET2005-06-29

More clearances from Volk Optical, Inc.

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Recalls naming K023221

K-number listed on FDA's recall record

Z-1685-2015 — Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.Class III·Terminated·Volk Optical Inc·20150227

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023221.

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