Cleared Special

K001737 - OPAQUE HERRICK PLUG, 0.3MM (FDA 510(k) Clearance)

Also includes:
0.5MM O.7MM
K001737 · Lacrimedics, Inc. · Ophthalmic device
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Jun 2000
Decision
12d
Days
-
Risk

K001737 is an FDA 510(k) clearance for the OPAQUE HERRICK PLUG, 0.3MM. Classified as Plug, Punctum (product code LZU).

Submitted by Lacrimedics, Inc. (Eastsound, US). The FDA issued a Cleared decision on June 19, 2000 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lacrimedics, Inc. devices

Submission Details

510(k) Number K001737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2000
Decision Date June 19, 2000
Days to Decision 12 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 110d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LZU Plug, Punctum
Device Class -