Cleared Traditional

DELTA PUNCTUM PLUG (K050851) - FDA 510(k) Clearance

K050851 · Delta Life Science, Inc. · Ophthalmic device
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Aug 2005
Decision
137d
Days
-
Risk

K050851 is an FDA 510(k) clearance for the DELTA PUNCTUM PLUG. Classified as Plug, Punctum (product code LZU).

Submitted by Delta Life Science, Inc. (Memphis, US). The FDA issued a Cleared decision on August 19, 2005 after a review of 137 days - within the typical 510(k) review window.

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 Delta Life Science, Inc. devices

Submission Details

510(k) Number K050851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2005
Decision Date August 19, 2005
Days to Decision 137 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 110d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -