Cleared Traditional

K854968 - BAUSCH & LOMB LENS CARRYING CASE

K854968 · Bausch & Lomb, Inc. · Ophthalmic device
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Apr 1986
Decision
114d
Days
-
Risk

K854968 is an FDA 510(k) clearance for the BAUSCH & LOMB LENS CARRYING CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on April 4, 1986 after a review of 114 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.

FDA 510(k) Submission Details - K854968

510(k) Number K854968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1985
Decision Date April 04, 1986
Days to Decision 114 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
4d slower than avg
Panel avg: 110d · This submission: 114d
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 42
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K854968.
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K860677 · Applied Laboratories, Inc. · May 1986
LENSKEEPER CONTACT LENS CARRYING CASE
K861642 · Allergan, Inc. · May 1986
WETTING & SOAKING HARD CONTACT LENS SOLUTION
K861712 · Maurry Biological Co. · May 1986
HARD CONTACT LENS CLEANING & SOAKING SOLUTION
K853808 · Maurry Biological Co. · Mar 1986
DAILY HARD CONTACT LENS CLEANER
K853809 · Maurry Biological Co. · Mar 1986
UVASORB-400
K854442 · Optatint, Inc. · Feb 1986
K854968 · BAUSCH & LOMB LENS CARRYING CASE
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