Cleared Traditional

K012096 - DISPOSABLE VITRECTOMY LENS

K012096 is an FDA 510(k) clearance for DISPOSABLE VITRECTOMY LENS, manufactured by Ocular Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HJK cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K012096 · Ocular Instruments, Inc. · Ophthalmic device
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Aug 2001
Decision
50d
Days
Class 2
Risk

K012096 is an FDA 510(k) clearance for the DISPOSABLE VITRECTOMY 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 August 24, 2001 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ocular Instruments, Inc. devices

FDA 510(k) Submission Details - K012096

510(k) Number K012096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2001
Decision Date August 24, 2001
Days to Decision 50 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
60d faster than avg
Panel avg: 110d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 33
Devices cleared under the same product code (HJK) and FDA review panel - the closest regulatory comparables to K012096.
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
K051103 · Haag-Streit USA, Inc. · Jun 2005
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
K050623 · Volk Optical, Inc. · Mar 2005
STAURENGHI WIDE FIELD SCANNING LASER LENS
K014170 · Ocular Instruments, Inc. · Mar 2002
ENDOVIEW SPPHIRE LENS SET
K971853 · American Medical Devices, Inc. · Aug 1997
MANDELKORN SUTURE LYSIS LENS
K933976 · Ocular Instruments, Inc. · Nov 1994
RITCH NYLON SUTURE LASER LENS
K933264 · Ocular Instruments, Inc. · Oct 1994