The following data is part of a premarket notification filed by Oculus Private Limited with the FDA for Freshkon 1-day Alluring Eyes (etafilcon A) Soft (hydrophilic) Contact Lens For Daily Wear Freshkon 1-day Mosaic (etafilc.
| Device ID | K122315 |
| 510k Number | K122315 |
| Device Name: | FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | OCULUS PRIVATE LIMITED 33 Golden Eagle Lane Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls OCULUS PRIVATE LIMITED 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2013-02-15 |