Optimedica Corporation is one of 13008 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Optimedica Corporation - FDA 510(k) Cleared Devices
Recent clearances: Catalys Precision Laser System, OPTIMEDICA CATALYS PRECISION LASER SYSTEM, CATALYS PRECISION LASER SYSTEM
8
Total
8
Cleared
0
Denied
Optimedica Corporation has 8 FDA 510(k) cleared medical devices. Based in Laguna Beach, US.
Historical record: 8 cleared submissions from 2006 to 2016. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Optimedica Corporation Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Johnson & Johnson Surgical Vision, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Optimedica Corporation
8 devices
Cleared
Sep 20, 2016
Catalys Precision Laser System
Ophthalmic
117d
Cleared
Sep 11, 2014
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
Ophthalmic
139d
Cleared
Aug 28, 2012
CATALYS PRECISION LASER SYSTEM
Ophthalmic
140d
Cleared
Dec 21, 2011
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
Ophthalmic
28d
Cleared
May 04, 2010
PASCAL STREAMLINE PHOTOCOAGULATOR
Ophthalmic
119d
Cleared
Jul 15, 2009
PASCAL PHOTOCOAGULATOR, PASCAL-US
General & Plastic Surgery
36d
Cleared
Sep 09, 2008
PASCAL SYNTHESIS DELIVERY SYSTEM
General & Plastic Surgery
82d
Cleared
Oct 19, 2006
OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE
General & Plastic Surgery
70d