Cleared Traditional

K895342 - COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST (FDA 510(k) Clearance)

K895342 · Lacrimedics, Inc. · Ophthalmic device
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Nov 1989
Decision
63d
Days
-
Risk

K895342 is an FDA 510(k) clearance for the COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST. Classified as Plug, Punctum (product code LZU).

Submitted by Lacrimedics, Inc. (Rosemead, US). The FDA issued a Cleared decision on November 2, 1989 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 Lacrimedics, Inc. devices

Submission Details

510(k) Number K895342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1989
Decision Date November 02, 1989
Days to Decision 63 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
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 -