The following data is part of a premarket notification filed by Supervision Optimax Sdn Bhd with the FDA for Aveo 1-day Aspheric Soft Contact Lens (omafilcon A).
| Device ID | K162223 |
| 510k Number | K162223 |
| Device Name: | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | SUPERVISION OPTIMAX SDN BHD LOT 38, PUTRA INDUSTRIAL PARK, BUKIT RAHMAN PUTRA Sungai Buloh, MY 40160 |
| Contact | Yap Peak Geeh |
| Correspondent | Yap Peak Geeh SUPERVISION OPTIMAX SDN BHD LOT 38, PUTRA INDUSTRIAL PARK, BUKIT RAHMAN PUTRA Sungai Buloh, MY 40160 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-08 |
| Decision Date | 2017-01-04 |
| Summary: | summary |