The following data is part of a premarket notification filed by Supervision Optimax Sdn Bhd with the FDA for Aveo (omafilcon A) Soft (hydrophilic) Contact Lenses.
| Device ID | K180985 |
| 510k Number | K180985 |
| Device Name: | Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses |
| 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 | 2018-04-13 |
| Decision Date | 2018-06-08 |
| Summary: | summary |