The following data is part of a premarket notification filed by Unicon Optical Co., Ltd with the FDA for Unicon Hydrogel (hioxifilcon A) Soft (hydrophilic) Contact Lens.
| Device ID | K191929 |
| 510k Number | K191929 |
| Device Name: | UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | UNICON Optical CO., LTD No 16, Gongye E. 9th Rd. Hsinchu Science Park, Baoshan Township Hsinchu County, TW 30075 |
| Contact | Hsiao-wei Shen |
| Correspondent | Hsiao-wei Shen UNICON Optical CO., LTD No 16, Gongye E. 9th Rd. Hsinchu Science Park, Baoshan Township Hsinchu County, TW 30075 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-19 |
| Decision Date | 2019-09-17 |
| Summary: | summary |