Cleared Traditional

K894162 - OPTISOL

K894162 · Chiron Ophthalmics · Ophthalmic device
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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

FDA 510(k) Submission Details - K894162

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.

LYX Device Classification - Class 0,

Product Code LYX Media, Corneal Storage
Device Class -