Cleared Traditional

K912253 - LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING

K912253 is an FDA 510(k) clearance for LANDERS 3 STRUT IRRIGATING VITRECTOMY L..., manufactured by Ocular Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K912253 · Ocular Instruments, Inc. · Ophthalmic device
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Aug 1991
Decision
78d
Days
Class 2
Risk

K912253 is an FDA 510(k) clearance for the LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on August 7, 1991 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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.

FDA 510(k) Submission Details - K912253

510(k) Number K912253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1991
Decision Date August 07, 1991
Days to Decision 78 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
32d faster than avg
Panel avg: 110d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQE Device Classification - Class 2, Special Controls

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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 - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 148
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K912253.
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K904909 · Visioncare Devices, Inc. · Jan 1991
K912253 · LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING
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