Cleared Traditional

CASE, CONTACT LENS, PLASTIC (K760046) - FDA 510(k) Clearance

K760046 · Tomlin B. Horsley, Jr. · Ophthalmic device
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Oct 1976
Decision
128d
Days
-
Risk

K760046 is an FDA 510(k) clearance for the CASE, CONTACT LENS, PLASTIC. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Tomlin B. Horsley, Jr. (Mchenry, US). The FDA issued a Cleared decision on October 21, 1976 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel. 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 Tomlin B. Horsley, Jr. devices

Submission Details

510(k) Number K760046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1976
Decision Date October 21, 1976
Days to Decision 128 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 110d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPX Lens, Contact (polymethylmethacrylate)
Device Class -