The following data is part of a premarket notification filed by Plexus Optix, Inc. with the FDA for Ethos Aquell (hioxifilcon A) One-day Soft (hydrophilic) Contact Lenses (59% Water).
| Device ID | K201268 |
| 510k Number | K201268 |
| Device Name: | Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Plexus Optix, Inc. 3333 Quality Drive Rancho Cordova, CA 95670 |
| Contact | Dave Delle Donne |
| Correspondent | Estela Lin Pegavision Corporation 2F-1, No.5, Shing Yeh St. Taoyuan, TW 33341 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-12 |
| Decision Date | 2020-10-21 |