Cleared Traditional

K050851 - DELTA PUNCTUM PLUG

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.

FDA 510(k) Submission Details - K050851

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 110d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

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K050851 · DELTA PUNCTUM PLUG
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