Cleared Traditional

K832073 - ELECTRIC INSTRUMENT TABLE

K832073 is the FDA 510(k) clearance for ELECTRIC INSTRUMENT TABLE by CooperVision, Inc.. It is a Class 1 Ophthalmic device (product code HMF) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K832073 · CooperVision, Inc. · Ophthalmic device
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Aug 1983
Decision
45d
Days
Class 1
Risk

K832073 is an FDA 510(k) clearance for the ELECTRIC INSTRUMENT TABLE. Classified as Stand, Instrument, Ac-powered, Ophthalmic (product code HMF), Class I - General Controls.

Submitted by CooperVision, Inc. (Walker, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1860 - 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 K832073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1983
Decision Date August 12, 1983
Days to Decision 45 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
65d faster than avg
Panel avg: 110d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMF Stand, Instrument, Ac-powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1860
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.