LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE— 510(k) K120756

Clearance details

Applicant

The Lagado Corp.

Product code

Code LPL

Device class

Class 2

Regulation

21 CFR 886.5925

Advisory panel

Ophthalmic

Date received

2012-03-13

Decision date

2013-05-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lauderdale By The Sea, FL, US

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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 →