ACUVUE (senofilcon A) Soft Contact Lens Multifocal— 510(k) K200243
Substantially EquivalentJohnson & Johnson Vision Care, Inc.
FDA 510(k) clearance K200243 for ACUVUE (senofilcon A) Soft Contact Lens Multifocal, Substantially Equivalent on 2020-03-17. Applicant: Johnson & Johnson Vision Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Johnson & Johnson Vision Care, 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
Recent devices under product code LPL
view all- K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
- 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
- K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
More clearances from Johnson & Johnson Vision Care, Inc.
view all- K210930 — ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)
- K180299 — ACUVUE OASYS (senofilcon A) with Photochromic Additive
- K160212 — ACUVUE (senofilcon C) Soft Contact Lens
- K141670 — ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
- K100349 — VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER
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.