Cleared Special

K021831 - OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB

K021831 · Lacrimedics, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Jul 2002
Decision
27d
Days
-
Risk

K021831 is an FDA 510(k) clearance for the OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP.... Classified as Plug, Punctum (product code LZU).

Submitted by Lacrimedics, Inc. (Eastsound, US). The FDA issued a Cleared decision on July 1, 2002 after a review of 27 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.

FDA 510(k) Submission Details - K021831

510(k) Number K021831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2002
Decision Date July 01, 2002
Days to Decision 27 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 110d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K021831.
SMART PLUG, MODEL 500
K022043 · Medennium, Inc. · Oct 2002
MOIST PUNCTAL PLUG SYSTEM
K021936 · Moist Medical, Inc. · Oct 2002
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
K020882 · Surgical Specialties Corp · Jul 2002
SOFT PLUG ABSORBABLE PLUG-SA
K013613 · Oasis Medical, Inc. · Jun 2002
OCCU-FLO PUNCTUM PLUGS
K001768 · U.S. Iol, Inc. · Sep 2000
BIOINSULATED SILICONE PUNCTUM PLUG
K001234 · Advanced Vision Science · Jul 2000
K021831 · OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB
Download PDF Lacrimedics, Inc.