ONE DAY FLAT PACK— 510(k) K102895
Substantially EquivalentMenicon Co, Ltd.
FDA 510(k) clearance K102895 for ONE DAY FLAT PACK, Substantially Equivalent on 2011-04-28. Applicant: Menicon Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Menicon Co, Ltd.
- Product code
- Product 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
- Grand Junction, CO, US
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- K262495 — Miru 1day UpSide (midafilcon A)
- K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
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
- K180819 — One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
- K180004 — Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
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.