Company ยท US
Optimedica Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2016. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 20, 2016 | K161455 | Catalys Precision Laser System Optimedica Corporation | OOE |
| Sep 11, 2014 | K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM Optimedica Corporation | OOE |
| Aug 28, 2012 | K121091 | CATALYS PRECISION LASER SYSTEM Optimedica Corporation | OOE |
| Dec 21, 2011 | K113479 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM Optimedica Corporation | OOE |
| May 4, 2010 | K100019 | PASCAL STREAMLINE PHOTOCOAGULATOR Optimedica Corporation | HQF |
| Jul 15, 2009 | K091666 | PASCAL PHOTOCOAGULATOR, PASCAL-US Optimedica Corporation | GEX |
| Sep 9, 2008 | K081744 | PASCAL SYNTHESIS DELIVERY SYSTEM Optimedica Corporation | GEX |
| Oct 19, 2006 | K062336 | OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE Optimedica Corporation | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2015 | Optimedica Corporation Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05
The OptiMedica Catalys Precision Laser System is indicated for use in patients und Terminated |
OOE | K141079 |
| Jan 8, 2014 | Optimedica Corporation Catalys Precision Laser System (United States) - Catalys-U:
Catalys Precision Laser System (International) - Catalys I
200-240V ~, 50/60 Hz, 15A,
(2) 15A Resettable CB:
Tested and complies with FCC P Terminated |
OOE | K121091 |