The following data is part of a premarket notification filed by Innova Vision Inc. with the FDA for Discon Daily (etafilcon A) One-day Soft (hydrophilic) Contact Lens.
| Device ID | K053191 |
| 510k Number | K053191 |
| Device Name: | DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS |
| Classification | Lens, Contact, (disposable) |
| Applicant | INNOVA VISION INC. 2904 N. BOLDT DRIVE Flaggstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich INNOVA VISION INC. 2904 N. BOLDT DRIVE Flaggstaff, AZ 86001 |
| Product Code | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-15 |
| Decision Date | 2006-05-12 |
| Summary: | summary |