The following data is part of a premarket notification filed by Hydrogel Vision Corporation with the FDA for Extreme H2o 54% (hioxifilcon D) Soft Contact Lens (spherical And Toric).
| Device ID | K051430 |
| 510k Number | K051430 |
| Device Name: | EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | HYDROGEL VISION CORPORATION 7575 COMMERCE COURT Sarasota, FL 34243 |
| Contact | Donna Hovanec |
| Correspondent | Donna Hovanec HYDROGEL VISION CORPORATION 7575 COMMERCE COURT Sarasota, FL 34243 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-01 |
| Decision Date | 2005-07-18 |
| Summary: | summary |