GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES— 510(k) K991000

Clearance details

Applicant

Wesley Jessen Corp.

Product code

Code LPL

Device class

Class 2

Regulation

21 CFR 886.5925

Advisory panel

Ophthalmic

Date received

1999-03-24

Decision date

1999-06-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Des Plaines, IL, US

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• K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more2026-03-19

• K000439 — DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C2000-03-20
• K994335 — PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS2000-03-20
• K993935 — DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI1999-12-21
• K991550 — FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS1999-05-14
• K982988 — PRECISION UV (VASURFILCON A)1999-01-06

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 →