The following data is part of a premarket notification filed by Unicon Optical Co., Ltd with the FDA for Unicon Hydrogel With Unicon Polymer (etafilcon A) Soft (hydrophilic) Daily Disposable Contac.
| Device ID | K182734 |
| 510k Number | K182734 |
| Device Name: | Unicon Hydrogel With Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac |
| 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 | 2018-09-28 |
| Decision Date | 2019-05-16 |
| Summary: | summary |