Cleared Traditional

OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED (K921729) - FDA 510(k) Clearance

K921729 · Chiron Intraoptics · Ophthalmic device
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Jun 1992
Decision
76d
Days
-
Risk

K921729 is an FDA 510(k) clearance for the OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED. Classified as Media, Corneal Storage (product code LYX).

Submitted by Chiron Intraoptics (Irvine, US). The FDA issued a Cleared decision on June 9, 1992 after a review of 76 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 Chiron Intraoptics devices

Submission Details

510(k) Number K921729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1992
Decision Date June 09, 1992
Days to Decision 76 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 110d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYX Media, Corneal Storage
Device Class -