The following data is part of a premarket notification filed by Vision Science Co.,ltd. with the FDA for Eyereve (hioxifilcon D) Soft (hydrophilic) Contact Lens For Daily Wear.
| Device ID | K161124 |
| 510k Number | K161124 |
| Device Name: | EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens For Daily Wear |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | VISION SCIENCE CO.,LTD. 7, JAIN-RO 7-GIL, JIAN-MYEON Gyeongsangbuk-do, KR 712852 |
| Contact | Oh In-whan |
| 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 | 2016-04-21 |
| Decision Date | 2016-08-26 |
| Summary: | summary |