UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR— 510(k) K141917
Substantially EquivalentUnicon Optical Co., Ltd.
FDA 510(k) clearance K141917 for UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR, Substantially Equivalent on 2014-10-17. Applicant: Unicon Optical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Unicon Optical 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
- New Taipei, TW
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More clearances from Unicon Optical Co., Ltd.
view all- K241707 — OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL
- K213216 — Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
- K191929 — UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
- K182734 — Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac
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.