Cleared Traditional

K013613 - SOFT PLUG ABSORBABLE PLUG-SA (FDA 510(k) Clearance)

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

Submission Details

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
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 110d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -