VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER— 510(k) K994318
Substantially EquivalentVistakon, Johnson & Johnson Vision Products, Inc.
FDA 510(k) clearance K994318 for VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER, Substantially Equivalent on 2000-02-23. Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- 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
- Traditional
- Location
- Jacksonville, FL, US
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More clearances from Vistakon, Johnson & Johnson Vision Products, Inc.
view all- K994324 — ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
- K991163 — VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR
- K991134 — ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR
- K983912 — VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER
- K964612 — VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT
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.