EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear— 510(k) K161124
Substantially EquivalentVision Science Co., Ltd.
FDA 510(k) clearance K161124 for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Substantially Equivalent on 2016-08-26. Applicant: Vision Science Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Vision Science 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
- Gyeongsangbuk-Do, KR
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- 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
More clearances from Vision Science Co., Ltd.
view allAdverse 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.