Cleared Traditional

LENS, CONTACT, HARD (K770582) - FDA 510(k) Clearance

K770582 · Berea Contact Lens, Inc. · Ophthalmic device
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May 1977
Decision
39d
Days
-
Risk

K770582 is an FDA 510(k) clearance for the LENS, CONTACT, HARD. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Berea Contact Lens, Inc. (Walker, US). The FDA issued a Cleared decision on May 6, 1977 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.

View all Berea Contact Lens, Inc. devices

Submission Details

510(k) Number K770582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1977
Decision Date May 06, 1977
Days to Decision 39 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 110d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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