C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS— 510(k) K041608
Substantially EquivalentUnilens Corp., USA
FDA 510(k) clearance K041608 for C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS, Substantially Equivalent on 2004-07-07. Applicant: Unilens Corp., USA. Device class: 2.
Clearance details
- Applicant
- Unilens Corp., USA
- Product code
- Code LPL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Largo, FL, US
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- K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more
- K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more
- K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS +1 more
More clearances from Unilens Corp., USA
view all- K142851 — CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens
- K121652 — CVUE ADVANCED HYDRA VUE
- K110452 — SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
- K100456 — CVUE ADVANCED DEFINITIVE
- K082393 — CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
Adverse events under product code LPL
product code LPL- Injury
- 988
- Other
- 4
- Total
- 992
Source: openFDA MAUDE database, through . 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.