LensGiene Sterile Saline Solution— 510(k) K161622

Substantially Equivalent

Optics Laboratory, Inc.

FDA 510(k) clearance K161622 for LensGiene Sterile Saline Solution, Substantially Equivalent on 2016-08-11. Applicant: Optics Laboratory, Inc..

Clearance details

Applicant: Optics Laboratory, Inc.
Product code: Code LPN
Advisory panel: Ophthalmic
Date received: 2016-06-13
Decision date: 2016-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Monte, CA, US

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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.