Cleared Special

K023221 - CONTACT LASER & DIAGNOSTIC LENSES

K023221 is an FDA 510(k) clearance for CONTACT LASER & DIAGNOSTIC 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 14-day FDA review.

K023221 · Volk Optical, Inc. · Ophthalmic device
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Oct 2002
Decision
14d
Days
Class 2
Risk

K023221 is an FDA 510(k) clearance for the CONTACT LASER & DIAGNOSTIC LENSES. 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 October 11, 2002 after a review of 14 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 - K023221

510(k) Number K023221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2002
Decision Date October 11, 2002
Days to Decision 14 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 110d · This submission: 14d
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 K023221.
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
K050623 · Volk Optical, Inc. · Mar 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
LUNEAU 3 MIRROR LENS
K022413 · Luneau SA · Sep 2002
STAURENGHI WIDE FIELD SCANNING LASER LENS
K014170 · Ocular Instruments, Inc. · Mar 2002
DISPOSABLE VITRECTOMY LENS
K012096 · Ocular Instruments, Inc. · Aug 2001
K023221 · CONTACT LASER & DIAGNOSTIC LENSES
Download PDF Volk Optical, Inc.