Cleared Traditional

POLYCORE (K822542) - FDA 510(k) Clearance

K822542 · Polycore Optical Pte , Ltd. · Ophthalmic device
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Dec 1982
Decision
126d
Days
-
Risk

K822542 is an FDA 510(k) clearance for the POLYCORE.

Submitted by Polycore Optical Pte , Ltd. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1982 after a review of 126 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 Polycore Optical Pte , Ltd. devices

Submission Details

510(k) Number K822542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1982
Decision Date December 27, 1982
Days to Decision 126 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 110d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -