Cleared Traditional

K870203 - KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K870203 · Keeler Instruments, Inc. · Ophthalmic device
Feb 1987
Decision
23d
Days
Class 1
Risk

K870203 is an FDA 510(k) clearance for the KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5. Classified as Telescope, Spectacle, Low-vision (product code HKK), Class I - General Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on February 12, 1987 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5870 - 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.

Submission Details

510(k) Number K870203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1987
Decision Date February 12, 1987
Days to Decision 23 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 156d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKK Telescope, Spectacle, Low-vision
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5870
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.