Cleared Traditional

K890714 - LACRIMAL EFFICIENCY TEST (TM) (FDA 510(k) Clearance)

K890714 · Lacrimedics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Lacrimedics, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 110d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -