BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens— 510(k) K220143
Substantially EquivalentShenzhen Dashicheng Optical Technology Co., Ltd.
FDA 510(k) clearance K220143 for BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens, Substantially Equivalent on 2022-09-08. Applicant: Shenzhen Dashicheng Optical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Dashicheng Optical Technology 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
- Shenzhen, CN
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.