Cleared Traditional

PUNCTUAL OCCLUDER (K970631) - FDA 510(k) Clearance

K970631 · Odyssey Medical, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Apr 1997
Decision
63d
Days
-
Risk

K970631 is an FDA 510(k) clearance for the PUNCTUAL OCCLUDER. Classified as Plug, Punctum (product code LZU).

Submitted by Odyssey Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on April 23, 1997 after a review of 63 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 Odyssey Medical, Inc. devices

Submission Details

510(k) Number K970631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1997
Decision Date April 23, 1997
Days to Decision 63 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
47d faster than avg
Panel avg: 110d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -