Tomey Corporation - FDA 510(k) Cleared Devices
Recent clearances: Tomey Optical Biometer OA-2000 (OA-2000), Tomey Cornea/Anterior Segment OCT (CASIA2), Tomey Cornea/Anterior Segment OCT CASIA2
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Tomey Corporation Ophthalmic ✕
5 devices
Cleared
Dec 18, 2025
Tomey Optical Biometer OA-2000 (OA-2000)
Ophthalmic
142d
Cleared
CT
Jul 18, 2025
Tomey Cornea/Anterior Segment OCT (CASIA2)
Ophthalmic
143d
Cleared
CT
Apr 27, 2022
Tomey Cornea/Anterior Segment OCT CASIA2
Ophthalmic
209d
Cleared
CT
Jan 19, 2018
EM-4000 Specular Microscope
Ophthalmic
260d
Cleared
Nov 18, 2008
NON-CONTACT TONOMETER, MODEL FT-1000
Ophthalmic
383d