The following data is part of a premarket notification filed by Innova Vision Inc. with the FDA for Discon (etafilcon A) Soft (hydrophilic) Contact Lens For Daily Wear.
| Device ID | K051129 |
| 510k Number | K051129 |
| Device Name: | DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | INNOVA VISION INC. 3892 SOUTH AMERICA WEST TRAIL Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich INNOVA VISION INC. 3892 SOUTH AMERICA WEST TRAIL 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 | 2005-05-03 |
| Decision Date | 2005-08-12 |
| Summary: | summary |