ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)— 510(k) K161098
Substantially EquivalentJoowon Innovation Co., Ltd.
FDA 510(k) clearance K161098 for ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color), Substantially Equivalent on 2016-08-22. Applicant: Joowon Innovation Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Joowon Innovation 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
- Cheonan-Si, Seobuk-Gu, KR
Recent devices under product code LPL
view all- K262495 — Miru 1day UpSide (midafilcon A)
- K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
- K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more
- 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
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.