Cleared Traditional

K222164 - Visant Medical Canalicular Plug (FDA 510(k) Clearance)

K222164 · Visant Medical, Inc. · Ophthalmic device
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Dec 2022
Decision
155d
Days
-
Risk

K222164 is an FDA 510(k) clearance for the Visant Medical Canalicular Plug. Classified as Plug, Punctum (product code LZU).

Submitted by Visant Medical, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 23, 2022 after a review of 155 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 Visant Medical, Inc. devices

Submission Details

510(k) Number K222164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2022
Decision Date December 23, 2022
Days to Decision 155 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
45d slower than avg
Panel avg: 110d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -

Regulatory Consultant

Regulatory Pathways Group, Inc.
Lee Kramm

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT04817085 Completed Interventional Industry-sponsored

An Evaluation of the Clinical Utility and Safety of the Visant Medical Canalicular Plug

Prospective Multicenter, Randomized, Double-Masked, Controlled Trial to Evaluate Clinical Utility and Safety of the Visant Medical Canalicular Device in Subjects Who Are Candidates for Occlusion With Punctal or Canalicular Plugs

156
Patients (actual)
5
Sites
Treatment
Purpose
Double blind
Masking
Condition studied Dry Eye
Study design Parallel
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Principal investigator Roger Albright
Sponsor Visant Medical, Inc. (industry)
Started 2020-10-06 → Primary completion 2022-02-09
Primary outcome
Mean change in Schirmer's score from baseline to Month 3 compared to commercially available plug
Secondary outcome
Proportion of responders achieving improvement from Baseline in Ocular Surface Disease Index (OSDI) score by a Minimal Clinically Important Difference (MCID).
Study completed - no results published. This trial concluded in 2022 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov