Cleared Traditional

OPTISOL (K894162) - FDA 510(k) Clearance

K894162 · Chiron Ophthalmics · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
212d
Days
-
Risk

K894162 is an FDA 510(k) clearance for the OPTISOL. Classified as Media, Corneal Storage (product code LYX).

Submitted by Chiron Ophthalmics (Irvine, US). The FDA issued a Cleared decision on January 12, 1990 after a review of 212 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 Chiron Ophthalmics devices

Submission Details

510(k) Number K894162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1989
Decision Date January 12, 1990
Days to Decision 212 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 110d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYX Media, Corneal Storage
Device Class -