Cleared Traditional

K780823 - CONTACT LENS CLEANSER

K780823 · Ketchum Laboratories, Inc. · Ophthalmic device
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Jun 1978
Decision
39d
Days
-
Risk

K780823 is an FDA 510(k) clearance for the CONTACT LENS CLEANSER. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Ketchum Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1978 after a review of 39 days - a notably fast clearance cycle.

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: 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 - K780823

510(k) Number K780823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1978
Decision Date June 30, 1978
Days to Decision 39 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
71d faster than avg
Panel avg: 110d · This submission: 39d
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 71
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K780823.
VISALENS ALL PURPOSE SOLUTION FOR LENS
K791523 · Pfizer, Inc. · Feb 1980
CONTACT LENSES MADE OF POLYMETHYLMETHACR
K792224 · Contact Lenses of the Pacific, Inc. · Dec 1979
VISALENS CONCENTRATED CLEANER CONT LENS
K791524 · Pfizer, Inc. · Nov 1979
AUTO-CON
K781007 · Barnes-Hind, Inc. · Jun 1978
LENS, CONTACT, HARD
K770582 · Berea Contact Lens, Inc. · May 1977
CASE, CONTACT LENS, PLASTIC
K760046 · Tomlin B. Horsley, Jr. · Oct 1976
K780823 · CONTACT LENS CLEANSER
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