Cleared Traditional

K001234 - BIOINSULATED SILICONE PUNCTUM PLUG

K001234 · Advanced Vision Science · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
85d
Days
-
Risk

K001234 is an FDA 510(k) clearance for the BIOINSULATED SILICONE PUNCTUM PLUG. Classified as Plug, Punctum (product code LZU).

Submitted by Advanced Vision Science (Goleta, US). The FDA issued a Cleared decision on July 11, 2000 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K001234

510(k) Number K001234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2000
Decision Date July 11, 2000
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 45
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K001234.
OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB
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SOFT PLUG ABSORBABLE PLUG-SA
K013613 · Oasis Medical, Inc. · Jun 2002
OCCU-FLO PUNCTUM PLUGS
K001768 · U.S. Iol, Inc. · Sep 2000
OPAQUE HERRICK PLUG, 0.3MM
K001737 · Lacrimedics, Inc. · Jun 2000
FLEXPLUG
K991130 · Eagle Vision, Inc. · Apr 1999
SURGIDEV SILICONE PUNCTUM PLUG
K980844 · Advanced Vision Science · May 1998
K001234 · BIOINSULATED SILICONE PUNCTUM PLUG
Download PDF FDA Summary Advanced Vision Scien…