Cleared Traditional

DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED (K921728) - FDA 510(k) Clearance

K921728 · Chiron Intraoptics · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
76d
Days
-
Risk

K921728 is an FDA 510(k) clearance for the DEXSOL 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 K921728 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 -