The following data is part of a premarket notification filed by Gelflex Laboratories with the FDA for Gelflex Synergy Soft Lens Hioxfilcon 49% Water Content Clear Or Blue Visitint; Gelflex Hioxifilcon Soft Contact Lens 49%.
| Device ID | K030027 |
| 510k Number | K030027 |
| Device Name: | GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | GELFLEX LABORATORIES 3 HUTTON ST., OSBORNE PARK Perth, Western, Wa, AU 6017 |
| Contact | Peter G Bryant |
| Correspondent | Peter G Bryant GELFLEX LABORATORIES 3 HUTTON ST., OSBORNE PARK Perth, Western, Wa, 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 | 2003-01-03 |
| Decision Date | 2003-04-01 |