Cleared Traditional

K933264 - RITCH NYLON SUTURE LASER LENS

K933264 is the FDA 510(k) clearance for RITCH NYLON SUTURE LASER LENS by Ocular Instruments, Inc.. It is a Class 2 Ophthalmic device (product code HJK) cleared through the Traditional 510(k) pathway after a 482-day FDA review.

K933264 · Ocular Instruments, Inc. · Ophthalmic device
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Oct 1994
Decision
482d
Days
Class 2
Risk

K933264 is an FDA 510(k) clearance for the RITCH NYLON SUTURE LASER LENS. Classified as Lens, Contact, Polymethylmethacrylate, Diagnostic (product code HJK), Class II - Special Controls.

Submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on October 31, 1994 after a review of 482 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1385 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Ocular Instruments, Inc. devices

Submission Details

510(k) Number K933264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1993
Decision Date October 31, 1994
Days to Decision 482 days
Submission Type Traditional
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
372d slower than avg
Panel avg: 110d · This submission: 482d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (HJK) and FDA review panel - the closest regulatory comparables to K933264.
STAURENGHI WIDE FIELD SCANNING LASER LENS
K014170 · Ocular Instruments, Inc. · Mar 2002
DISPOSABLE VITRECTOMY LENS
K012096 · Ocular Instruments, Inc. · Aug 2001
MANDELKORN SUTURE LYSIS LENS
K933976 · Ocular Instruments, Inc. · Nov 1994
50 DEGREE HRI PRISM LENS
K941420 · Ocular Instruments, Inc. · Aug 1994
PEDIATRIC VITRECTOMY LENS SET
K914051 · Ocular Instruments, Inc. · Dec 1991
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET
K914117 · Ocular Instruments, Inc. · Nov 1991