Cleared Traditional

SITE GILLS STYLE I/A HANDPIECE (K842459) - FDA 510(k) Clearance

K842459 · Chiron Vision Corp. · Ophthalmic device
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Aug 1984
Decision
54d
Days
-
Risk

K842459 is an FDA 510(k) clearance for the SITE GILLS STYLE I/A HANDPIECE.

Submitted by Chiron Vision Corp. (Irvine, US). The FDA issued a Cleared decision on August 15, 1984 after a review of 54 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 Vision Corp. devices

Submission Details

510(k) Number K842459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1984
Decision Date August 15, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 110d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -