Cleared Traditional

LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT (K897190) - FDA 510(k) Clearance

K897190 · Look, Inc. · Ophthalmic device
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Mar 1990
Decision
90d
Days
-
Risk

K897190 is an FDA 510(k) clearance for the LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT. Classified as Plug, Punctum (product code LZU).

Submitted by Look, Inc. (Ada, US). The FDA issued a Cleared decision on March 28, 1990 after a review of 90 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.

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Submission Details

510(k) Number K897190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1989
Decision Date March 28, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -