Cleared Traditional

K890714 - LACRIMAL EFFICIENCY TEST (TM)

K890714 · Lacrimedics, Inc. · Ophthalmic device
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May 1989
Decision
93d
Days
-
Risk

K890714 is an FDA 510(k) clearance for the LACRIMAL EFFICIENCY TEST (TM). Classified as Plug, Punctum (product code LZU).

Submitted by Lacrimedics, Inc. (Rosemead, US). The FDA issued a Cleared decision on May 17, 1989 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K890714

510(k) Number K890714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1989
Decision Date May 17, 1989
Days to Decision 93 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
17d faster than avg
Panel avg: 110d · This submission: 93d
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 K890714.
LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K897190 · Look, Inc. · Mar 1990
HERRICK LACRIMAL PLUG TM.
K896175 · Lacrimedics, Inc. · Jan 1990
COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
K895342 · Lacrimedics, Inc. · Nov 1989
TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K890919 · Eagle Vision, Inc. · May 1989
EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE
K890920 · Eagle Vision, Inc. · Apr 1989
K890714 · LACRIMAL EFFICIENCY TEST (TM)
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