Cleared Traditional

SOFT LENS REMOVER/INSERTER/MANIPULATOR (K780664) - FDA 510(k) Clearance

Class I Ophthalmic device.

K780664 · Dmv Contact Lens Co. · Ophthalmic device
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May 1978
Decision
27d
Days
Class 1
Risk

K780664 is an FDA 510(k) clearance for the SOFT LENS REMOVER/INSERTER/MANIPULATOR. Classified as Inserter/remover Contact Lens (product code KYE), Class I - General Controls.

Submitted by Dmv Contact Lens Co. (Mchenry, US). The FDA issued a Cleared decision on May 17, 1978 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5420 - 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 Dmv Contact Lens Co. devices

Submission Details

510(k) Number K780664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1978
Decision Date May 17, 1978
Days to Decision 27 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 110d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYE Inserter/remover Contact Lens
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5420
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.