Cleared Traditional

OPTOCRYL CONTACT LENS BLANKS (K810130) - FDA 510(k) Clearance

K810130 · Optacryl, Inc. · Ophthalmic device
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Jun 1981
Decision
143d
Days
-
Risk

K810130 is an FDA 510(k) clearance for the OPTOCRYL CONTACT LENS BLANKS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Optacryl, Inc. (Walker, US). The FDA issued a Cleared decision on June 11, 1981 after a review of 143 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 Optacryl, Inc. devices

Submission Details

510(k) Number K810130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1981
Decision Date June 11, 1981
Days to Decision 143 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 110d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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