The following data is part of a premarket notification filed by Joowon Innovation Co., Ltd. with the FDA for Chicview (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (tinted/color).
| Device ID | K161098 |
| 510k Number | K161098 |
| Device Name: | ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | JOOWON INNOVATION CO., LTD. 44, SURETEO 1-GIL Cheonan-si, Seobuk-gu, KR |
| Contact | Lee Hae-hang |
| Correspondent | Bret Andre EYEREG CONSULTING, INC 6119 Canter Ln West Linn, OR 97068 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-19 |
| Decision Date | 2016-08-22 |
| Summary: | summary |