LIFESTYLE BREAK THRU (POLYMACON)— 510(k) K965012

Substantially Equivalent

The Lifestyle Co., Inc.

FDA 510(k) clearance K965012 for LIFESTYLE BREAK THRU (POLYMACON), Substantially Equivalent on 1997-03-11. Applicant: The Lifestyle Co., Inc..

Clearance details

Applicant: The Lifestyle Co., Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1996-12-16
Decision date: 1997-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morganville, NJ, US

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Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

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.