Miru 1day UpSide (midafilcon A)— 510(k) K193399
Substantially EquivalentMenicon Co, Ltd.
FDA 510(k) clearance K193399 for Miru 1day UpSide (midafilcon A), Substantially Equivalent on 2020-06-17. 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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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.