Cleared Traditional

K780931 - SOFT LENS INSERTER

K780931 is an FDA 510(k) clearance for SOFT LENS INSERTER, manufactured by Soft-Sert. The device is a Class 1 Ophthalmic device with product code KYE cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K780931 · Soft-Sert · Ophthalmic device
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Jun 1978
Decision
22d
Days
Class 1
Risk

K780931 is an FDA 510(k) clearance for the SOFT LENS INSERTER. Classified as Inserter/remover Contact Lens (product code KYE), Class I - General Controls.

Submitted by Soft-Sert (Mchenry, US). The FDA issued a Cleared decision on June 28, 1978 after a review of 22 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.

FDA 510(k) Submission Details - K780931

510(k) Number K780931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1978
Decision Date June 28, 1978
Days to Decision 22 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
88d faster than avg
Panel avg: 110d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

KYE Device Classification - Class 1, General Controls

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.

Regulatory Peers - KYE Inserter/remover Contact Lens

All 11
Devices cleared under the same product code (KYE) and FDA review panel - the closest regulatory comparables to K780931.
LENSERT CONTACT LENS CLEANING & INSERT
K830738 · Jermyn Specialties of California · Jun 1983
DMV ANGLER
K830496 · Dmv Contact Lens Co. · Mar 1983
REMOVER, SOFT-SERT CONTACT LENS
K782140 · Mcmurray and Pendergost · Feb 1979
CONTACT LENS REMOVER AND INSERTER
K780663 · Dmv Contact Lens Co. · May 1978
SOFT LENS REMOVER/INSERTER/MANIPULATOR
K780664 · Dmv Contact Lens Co. · May 1978
K780931 · SOFT LENS INSERTER
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