The following data is part of a premarket notification filed by Innova Vision Inc. with the FDA for Calaview Color (etafilcon A) Soft (hydrophilic) Contact Lens For Daily Wear Modification.
| Device ID | K112373 |
| 510k Number | K112373 |
| Device Name: | CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | INNOVA VISION INC. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich INNOVA VISION INC. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-17 |
| Decision Date | 2012-08-17 |
| Summary: | summary |