One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens— 510(k) K180819
Substantially EquivalentMenicon Co, Ltd.
FDA 510(k) clearance K180819 for One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens, Substantially Equivalent on 2018-05-16. Applicant: Menicon Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Menicon Co, Ltd.
- 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
- Nagoya, JP
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More clearances from Menicon Co, Ltd.
view all- K253795 — MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution
- K193399 — Miru 1day UpSide (midafilcon A)
- K191872 — Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
- K180004 — Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
- K173136 — Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
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.