SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR— 510(k) K033655

Clearance details

Applicant

Soflex Contact Lens Industries , Ltd.

Product code

Code LPL

Device class

Class 2

Regulation

21 CFR 886.5925

Advisory panel

Ophthalmic

Date received

2003-11-21

Decision date

2004-07-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Littleton, CO, US

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• K030842 — ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP2003-06-06
• K020642 — SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR2002-05-24
• K013467 — TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR2001-11-20
• K013469 — EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR2001-11-20
• K011256 — TORIC LITE LENS2001-07-17

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 →