The following data is part of a premarket notification filed by Oculus Private Limited with the FDA for Freshkonalluring Eyes, Freshkon Colors Fusion, Freshkoncolors Fusion Sparklers, Freshkon Mosaic, Freshkon Glitzi.
| Device ID | K103132 |
| 510k Number | K103132 |
| Device Name: | FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | OCULUS PRIVATE LIMITED 5401 S COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls OCULUS PRIVATE LIMITED 5401 S COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-25 |
| Decision Date | 2011-09-08 |