Cleared Traditional

K897190 - LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT

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.

FDA 510(k) Submission Details - K897190

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
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 K897190.
EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
K905427 · Eagle Vision, Inc. · Jun 1991
OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
K911108 · G.W.B. Intl., Ltd. · May 1991
LACRIMAL PLUG
K905750 · Tamcenan Corp. · Mar 1991
HERRICK LACRIMAL PLUG TM.
K896175 · Lacrimedics, Inc. · Jan 1990
COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
K895342 · Lacrimedics, Inc. · Nov 1989
LACRIMAL EFFICIENCY TEST (TM)
K890714 · Lacrimedics, Inc. · May 1989
K897190 · LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
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