Cleared Traditional

MULTI-VIEW BIFOCALS (K913081) - FDA 510(k) Clearance

K913081 · Camp Contact Lenses · Ophthalmic device
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Oct 1991
Decision
107d
Days
-
Risk

K913081 is an FDA 510(k) clearance for the MULTI-VIEW BIFOCALS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Camp Contact Lenses (Houston, US). The FDA issued a Cleared decision on October 23, 1991 after a review of 107 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.

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Submission Details

510(k) Number K913081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date October 23, 1991
Days to Decision 107 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 110d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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