Cleared Traditional

SIGHT SAVER ALL PURPOSE LENS CARRYING CASE (K852384) - FDA 510(k) Clearance

K852384 · Bausch & Lomb, Inc. · Ophthalmic device
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Jul 1985
Decision
56d
Days
-
Risk

K852384 is an FDA 510(k) clearance for the SIGHT SAVER ALL PURPOSE 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 July 31, 1985 after a review of 56 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.

View all Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K852384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1985
Decision Date July 31, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 110d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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