Cleared Traditional

K915809 - VISITEC CANALICULAR STENT (FDA 510(k) Clearance)

K915809 · Visitec Co. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
62d
Days
-
Risk

K915809 is an FDA 510(k) clearance for the VISITEC CANALICULAR STENT. Classified as Plug, Punctum (product code LZU).

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on February 24, 1992 after a review of 62 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 Visitec Co. devices

Submission Details

510(k) Number K915809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date February 24, 1992
Days to Decision 62 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 110d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -