Medical Device Manufacturer · US , Malibu , CA

Iop, Inc. - FDA 510(k) Cleared Devices

9 submissions · 8 cleared · Since 1989

9

Total

8

Cleared

0

Denied

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

9 devices

1-9 of 9

Cleared May 08, 2009

KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT

Ophthalmic · 116d

Cleared Sep 27, 2006

Ophthalmic · 55d

Cleared Mar 15, 2006

SURGISIS OCULAR GRAFT

Ophthalmic · 77d

Cleared Aug 13, 2001

OSMED TISSUE EXPANDER

Ophthalmic · 145d

Cleared Feb 22, 2001

SUTUREGROOVE WEIGHT SIZING SET

Ophthalmic · 87d

Cleared Apr 17, 2000

Ophthalmic · 118d

Cleared Oct 16, 1997

MOA BONE / M-SPHERE

Ophthalmic · 132d

Cleared Aug 14, 1990

MODIFIED MOLTENO(TM) IMPLANTS

Ophthalmic · 90d

Cleared Feb 27, 1989

MOLTENO IMPLANT

Ophthalmic · 21d