Clearance details

Applicant: Vistakon
Product code: Code LPL
Device class: Class 2
Regulation: 21 CFR 886.5925
Advisory panel: Ophthalmic
Date received: 2004-08-23
Decision date: 2004-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Recent devices under product code LPL

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K262495 — Miru 1day UpSide (midafilcon A)2026-09-17
K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus2026-05-29
K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more2026-05-21
K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more2026-05-19
K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS +1 more2026-04-29

More clearances from Vistakon

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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 →

Recalls naming K042275

K-number listed on FDA's recall record

Z-1131-2019 — ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.Class II·Terminated·Johnson & Johnson Vision Care, Inc.·20190311
Z-1744-2020 — ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.Class II·Terminated·Johnson & Johnson Vision Care, Inc.·20171218
Z-1209-2018 — ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUSClass II·Terminated·Johnson & Johnson Vision Care, Inc.·20171019

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042275.