The following data is part of a premarket notification filed by Eyeyon Medical with the FDA for Eyeyon (hioxirilcon D) Soft (hydrophillc) Contactlensesfor Daily Wear, Hyper-cl (hioxirilcon D)therapeuticsoft (hydrophillc) Contact Lensesfor Daily Wear.
| Device ID | K153305 |
| 510k Number | K153305 |
| Device Name: | EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | EYEYON MEDICAL GOLDA MEIR 5 Nes Ziona, IL 7403649 |
| Contact | Malca Chen-zion |
| Correspondent | Bret Andre EYEREG CONSULTING, INC. 6119 CANTER LANE 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 | 2015-11-16 |
| Decision Date | 2016-04-08 |
| Summary: | summary |