Medical Device Manufacturer · US , Irvine , CA

American Optisurgical, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1995

Recent clearances: TX1 TISSUE REMOVAL SYSTEM, VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551, HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Optisurgical, Inc. Ophthalmic ✕

5 devices

1-5 of 5

Cleared Sep 22, 2008

VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551

Ophthalmic · 185d

Cleared Jul 09, 2002

HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030

Ophthalmic · 140d

Cleared Dec 26, 1995

Ophthalmic · 151d

Cleared Dec 26, 1995

DM001 DISPOSABLE PACK

Ophthalmic · 151d

Cleared Aug 16, 1995

AOI LC-40 PHACOEMULSIFIER

Ophthalmic · 90d