Cleared Traditional

Tear Pool Dissolvable Punctum Plugs (K190210) - FDA 510(k) Clearance

K190210 · Alphamed, Inc. · Ophthalmic device
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Oct 2019
Decision
262d
Days
-
Risk

K190210 is an FDA 510(k) clearance for the Tear Pool Dissolvable Punctum Plugs. Classified as Plug, Punctum (product code LZU).

Submitted by Alphamed, Inc. (El Paso, US). The FDA issued a Cleared decision on October 24, 2019 after a review of 262 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 Alphamed, Inc. devices

Submission Details

510(k) Number K190210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2019
Decision Date October 24, 2019
Days to Decision 262 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
152d slower than avg
Panel avg: 110d · This submission: 262d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -