Cleared Traditional

K850991 - LANDERS VITRECTOMY LENS RING SYSTEMS

K850991 is the FDA 510(k) clearance for LANDERS VITRECTOMY LENS RING SYSTEMS by Ocular Instruments, Inc.. It is a Class 1 Ophthalmic device (product code HNH) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K850991 · Ocular Instruments, Inc. · Ophthalmic device
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Mar 1985
Decision
18d
Days
Class 1
Risk

K850991 is an FDA 510(k) clearance for the LANDERS VITRECTOMY LENS RING SYSTEMS. Classified as Ring, Ophthalmic (flieringa) (product code HNH), Class I - General Controls.

Submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on March 29, 1985 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 K850991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1985
Decision Date March 29, 1985
Days to Decision 18 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 110d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNH Ring, Ophthalmic (flieringa)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.