Cleared Traditional

K883337 - PL 20/20 INFANT VISION TESTER (FDA 510(k) Clearance)

Class I Ophthalmic device.

K883337 · Optimed Technologies, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
83d
Days
Class 1
Risk

K883337 is an FDA 510(k) clearance for the PL 20/20 INFANT VISION TESTER. Classified as Chart, Visual Acuity (product code HOX), Class I - General Controls.

Submitted by Optimed Technologies, Inc. (Lawrence, US). The FDA issued a Cleared decision on October 31, 1988 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1150 - 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 Optimed Technologies, Inc. devices

Submission Details

510(k) Number K883337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date October 31, 1988
Days to Decision 83 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 110d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOX Chart, Visual Acuity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1150
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.