Cleared Traditional

PMMA CLASIC (K955777) - FDA 510(k) Clearance

K955777 · Rand Scientific Corp. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
May 1996
Decision
148d
Days
-
Risk

K955777 is an FDA 510(k) clearance for the PMMA CLASIC. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Rand Scientific Corp. (Sacramento, US). The FDA issued a Cleared decision on May 16, 1996 after a review of 148 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.

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Submission Details

510(k) Number K955777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1995
Decision Date May 16, 1996
Days to Decision 148 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 110d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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