PURILENS SALINE SOLUTION— 510(k) K002319

Name: FDA 510(k) clearance K002319
Creator: U.S. Food and Drug Administration
Published: 2000-08-30

Substantially Equivalent

Purilens, Inc.

FDA 510(k) clearance K002319 for PURILENS SALINE SOLUTION, Substantially Equivalent on 2000-08-30. Applicant: Purilens, Inc.. Device class: 2.

Clearance details

Applicant: Purilens, Inc.
Product code: Code LPN
Device class: Class 2
Regulation: 21 CFR 886.5928
Advisory panel: Ophthalmic
Date received: 2000-07-31
Decision date: 2000-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Port Riche, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LPN

product code LPN

Injury: 333
Other: 8
Total: 341

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.