CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS— 510(k) K992950

Substantially Equivalent

Prosthetic Soft Lens Corp.

FDA 510(k) clearance K992950 for CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS, Substantially Equivalent on 1999-11-18. Applicant: Prosthetic Soft Lens Corp..

Clearance details

Applicant: Prosthetic Soft Lens Corp.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1999-09-01
Decision date: 1999-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, 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.