Cleared Special

K050623 - VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D

K050623 is an FDA 510(k) clearance for VOLK DISPOSABLE VITRECTOMY LENSES, manufactured by Volk Optical, Inc.. The device is a Class 2 Ophthalmic device with product code HJK cleared through the Special 510(k) pathway after a 18-day FDA review.

K050623 · Volk Optical, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
18d
Days
Class 2
Risk

K050623 is an FDA 510(k) clearance for the VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VO.... Classified as Lens, Contact, Polymethylmethacrylate, Diagnostic (product code HJK), Class II - Special Controls.

Submitted by Volk Optical, Inc. (Rockville, US). The FDA issued a Cleared decision on March 28, 2005 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1385 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050623

510(k) Number K050623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2005
Decision Date March 28, 2005
Days to Decision 18 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 110d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

HJK Device Classification - Class 2, Special Controls

Product Code HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1385
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

All 40
Devices cleared under the same product code (HJK) and FDA review panel - the closest regulatory comparables to K050623.
Sensor Medical Family of Vitrectomy Lenses and Products
K142715 · Sensor Medical Technology, LLC · Dec 2014
SUPER VIEW DISPOSABLE BIOM LENS SET
K051630 · Insight Instruments, Inc. · Jun 2005
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
K051103 · Haag-Streit USA, Inc. · Jun 2005
DORC VITRECTOMY LENSES, MODEL 1284 SERIES
K033950 · Dutch Ophthalmic Research Center (D.O.R.C.) · Feb 2004
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
K030054 · Fci Ophthalmics, Inc. · Feb 2003
CONTACT LASER & DIAGNOSTIC LENSES
K023221 · Volk Optical, Inc. · Oct 2002
K050623 · VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
Download PDF FDA Summary Volk Optical, Inc.