Medical Device Manufacturer · US , Cambridge , MA

Tomey Corporation USA - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1991

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tomey Corporation USA Ophthalmic ✕

8 devices

1-8 of 8

Cleared Aug 14, 1997

Ophthalmic · 78d

Cleared Jun 24, 1997

IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM

Ophthalmic · 48d

Cleared May 09, 1997

TOMEY DTL ELECTRODE

Ophthalmic · 364d

Cleared Mar 01, 1995

VIDEO VISION ANALYZER (VIVA), VRB 100

Ophthalmic · 84d

Cleared Nov 22, 1994

TOMEY EM-1000 SPECULAR MICROSCOPE

Ophthalmic · 48d

Cleared Apr 05, 1993

TOMEY PROTON TONOMETER

Ophthalmic · 194d

Cleared Jul 15, 1992

TOMEY PE-300 PORTABLE ERG

Ophthalmic · 91d

Cleared Jun 17, 1991

PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480

Ophthalmic · 35d