Medical Device Manufacturer · US , Walker , MI

Fibra Sonics, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1980

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fibra Sonics, Inc. Ophthalmic ✕

3 devices

1-3 of 3

Cleared Feb 16, 1999

FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM

Ophthalmic · 90d

Cleared Mar 16, 1984

PHACO FRAGMENTOR GT-1

Ophthalmic · 88d

Cleared Dec 17, 1980

LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.

Ophthalmic · 79d