Cleared Traditional

K830738 - LENSERT CONTACT LENS CLEANING & INSERT

K830738 is an FDA 510(k) clearance for LENSERT CONTACT LENS CLEANING & INSERT, manufactured by Jermyn Specialties of California. The device is a Class 1 Ophthalmic device with product code KYE cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K830738 · Jermyn Specialties of California · Ophthalmic device
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Jun 1983
Decision
94d
Days
Class 1
Risk

K830738 is an FDA 510(k) clearance for the LENSERT CONTACT LENS CLEANING & INSERT. Classified as Inserter/remover Contact Lens (product code KYE), Class I - General Controls.

Submitted by Jermyn Specialties of California (Mchenry, US). The FDA issued a Cleared decision on June 10, 1983 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Jermyn Specialties of California devices

FDA 510(k) Submission Details - K830738

510(k) Number K830738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1983
Decision Date June 10, 1983
Days to Decision 94 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 110d · This submission: 94d
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.