Medical Device Manufacturer · AU , Perth, Western, Wa

Gelflex Laboratories - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1996

Total

Cleared

Denied

Gelflex Laboratories has 4 FDA 510(k) cleared medical devices. Based in Perth, Western, Wa, AU.

Historical record: 4 cleared submissions from 1996 to 2018. Primary specialty: Ophthalmic.

Browse the FDA 510(k) cleared devices submitted by Gelflex Laboratories Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Eyereg Consulting, Inc. as regulatory consultant.

Gelflex Laboratories is one of 80 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Gelflex Laboratories

4 devices

1-4 of 4

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Jun 08, 2026