Cleared Traditional

CONTACT LENS MATERL (K811010) - FDA 510(k) Clearance

K811010 · Paragon Optical Co. · Ophthalmic device
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Dec 1981
Decision
238d
Days
-
Risk

K811010 is an FDA 510(k) clearance for the CONTACT LENS MATERL. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Paragon Optical Co. (Mchenry, US). The FDA issued a Cleared decision on December 9, 1981 after a review of 238 days - an extended review 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: 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 Paragon Optical Co. devices

Submission Details

510(k) Number K811010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1981
Decision Date December 09, 1981
Days to Decision 238 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 110d · This submission: 238d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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