The following data is part of a premarket notification filed by Gelflex with the FDA for Gelflex Delta Soft Contact Lens Material Methafilcon A 55% Water Content Clear Or Blue Visitint, Gelflex Alpha Soft Cont.
| Device ID | K024003 |
| 510k Number | K024003 |
| Device Name: | GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | GELFLEX THREE HUTTON ST. OSBORNE PARK Perth, AU 6017 |
| Contact | Peter G Bryant |
| Correspondent | Peter G Bryant GELFLEX THREE HUTTON ST. OSBORNE PARK Perth, AU 6017 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-04 |
| Decision Date | 2003-02-05 |