Cleared Traditional

AUTOMATIC TANGENT SCREEN 50 (K832800) - FDA 510(k) Clearance

Class I Ophthalmic device.

K832800 · CooperVision, Inc. · Ophthalmic device
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Sep 1983
Decision
42d
Days
Class 1
Risk

K832800 is an FDA 510(k) clearance for the AUTOMATIC TANGENT SCREEN 50. Classified as Perimeter, Ac-powered (product code HOO), Class I - General Controls.

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on September 29, 1983 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1605 - 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 CooperVision, Inc. devices

Submission Details

510(k) Number K832800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date September 29, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 110d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOO Perimeter, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
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.