The following data is part of a premarket notification filed by Hydrogel Vision Corporation with the FDA for 59% Extreme H2o (hioxifilcon A) Soft Contact Lens.
| Device ID | K040303 |
| 510k Number | K040303 |
| Device Name: | 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | HYDROGEL VISION CORPORATION 6447 PARKLAND DR. Sarasota, FL 34243 -4035 |
| Contact | Donna Hovanec |
| Correspondent | Donna Hovanec HYDROGEL VISION CORPORATION 6447 PARKLAND DR. Sarasota, FL 34243 -4035 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-09 |
| Decision Date | 2005-02-02 |
| Summary: | summary |