SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT— 510(k) K000376

Substantially Equivalent

Specialty Ultravision, Inc.

FDA 510(k) clearance K000376 for SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT, Substantially Equivalent on 2000-03-21. Applicant: Specialty Ultravision, Inc..

Clearance details

Applicant: Specialty Ultravision, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2000-02-07
Decision date: 2000-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campbell, CA, 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.