Cleared Traditional

K913081 - MULTI-VIEW BIFOCALS

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.

View all Camp Contact Lenses devices

FDA 510(k) Submission Details - K913081

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.

HPX Device Classification - Class 0,

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

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 20
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K913081.
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K955777 · Rand Scientific Corp. · May 1996
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LENSKEEPER CONTACT LENS CARRYING CASE
K861642 · Allergan, Inc. · May 1986
BAUSCH & LOMB LENS CARRYING CASE
K854968 · Bausch & Lomb, Inc. · Apr 1986
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
K852384 · Bausch & Lomb, Inc. · Jul 1985
SENSITIVE EYES
K832706 · Bausch & Lomb, Inc. · Oct 1983