Medical Device Manufacturer · AU , Perth

Gelflex - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2001

Recent clearances: GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT, GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gelflex Ophthalmic ✕

2 devices

1-2 of 2

Cleared Feb 05, 2003

GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT...

Ophthalmic · 63d

Cleared Aug 24, 2001

GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT...

Ophthalmic · 137d