Cleared Traditional

K912366 - MAINSTER HIGH MAGNIFICATION LASER LENS

K912366 is the FDA 510(k) clearance for MAINSTER HIGH MAGNIFICATION 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 27-day FDA review.

K912366 · Ocular Instruments, Inc. · Ophthalmic device
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Jun 1991
Decision
27d
Days
Class 2
Risk

K912366 is an FDA 510(k) clearance for the MAINSTER HIGH MAGNIFICATION 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 June 25, 1991 after a review of 27 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

Submission Details

510(k) Number K912366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1991
Decision Date June 25, 1991
Days to Decision 27 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
83d faster than avg
Panel avg: 110d · This submission: 27d
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 K912366.
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
NMR-K FUNDUS LASER LENS
K910231 · Ocular Instruments, Inc. · Jan 1991
MAINSTER WIDE FIELD LASER LENS
K896198 · Ocular Instruments, Inc. · Dec 1989
WOLDOFF PRISMATIC BICONCAVE LENS
K894421 · Ocular Instruments, Inc. · Oct 1989