Cleared Traditional

K013613 - SOFT PLUG ABSORBABLE PLUG-SA

K013613 · Oasis Medical, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
234d
Days
-
Risk

K013613 is an FDA 510(k) clearance for the SOFT PLUG ABSORBABLE PLUG-SA. Classified as Plug, Punctum (product code LZU).

Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on June 27, 2002 after a review of 234 days - an extended review 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: 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.

View all Oasis Medical, Inc. devices

FDA 510(k) Submission Details - K013613

510(k) Number K013613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date June 27, 2002
Days to Decision 234 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
124d slower than avg
Panel avg: 110d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 36
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K013613.
MOIST PUNCTAL PLUG SYSTEM
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SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
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OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB
K021831 · Lacrimedics, Inc. · Jul 2002
OCCU-FLO PUNCTUM PLUGS
K001768 · U.S. Iol, Inc. · Sep 2000
BIOINSULATED SILICONE PUNCTUM PLUG
K001234 · Advanced Vision Science · Jul 2000
OPAQUE HERRICK PLUG, 0.3MM
K001737 · Lacrimedics, Inc. · Jun 2000