Cleared Traditional

K895342 - COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST

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.

FDA 510(k) Submission Details - K895342

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 110d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 48
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K895342.
LACRIMAL PLUG
K905750 · Tamcenan Corp. · Mar 1991
LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K897190 · Look, Inc. · Mar 1990
HERRICK LACRIMAL PLUG TM.
K896175 · Lacrimedics, Inc. · Jan 1990
LACRIMAL EFFICIENCY TEST (TM)
K890714 · Lacrimedics, Inc. · May 1989
TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K890919 · Eagle Vision, Inc. · May 1989
EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE
K890920 · Eagle Vision, Inc. · Apr 1989
K895342 · COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
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