FDA 510(k) Applications Submitted by Ken Nehmer
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K990007 |
01/04/1999 |
OPART, MODEL MRT-600 |
TOSHIBA AMERICA MRI, INC. |
| K240169 |
01/22/2024 |
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) |
Bausch and Lomb Incorporated |
| K120426 |
02/13/2012 |
VICTUS LASER PLATFORM |
TECHNOLAS PERFECT VISION GMBH |
| K000549 |
02/18/2000 |
OPART, MODEL MRT-600 |
TOSHIBA AMERICA MRI, INC. |
| K050422 |
02/18/2005 |
550 TXT TREATMENT TABLE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K991057 |
03/30/1999 |
EXTRA LARGE BODY COIL FOR OPART (MRT-600) |
TOSHIBA AMERICA MRI, INC. |
| K061097 |
04/19/2006 |
COHERENCE DOSIMETRIST, MODEL 2.2 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K141379 |
05/27/2014 |
VICTUS FEMTOSECOND LASER PLATFORM |
TECHNOLAS PERFECT VISION GMBH |
| K031764 |
06/09/2003 |
ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K132534 |
08/13/2013 |
VICTUS FEMTOSECOND LASER PLATFORM |
TECHNOLAS PERFECT VISION GMBH |
| K002531 |
08/16/2000 |
EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 |
TOSHIBA AMERICA MRI, INC. |
| K162342 |
08/22/2016 |
Stellaris Elite Vision Enhancement System |
Bausch + Lomb |
| K983110 |
09/04/1998 |
FLEXART,FLEXART/HYPER, VISART, VISART/HYPER |
TOSHIBA AMERICA MRI, INC. |
| K032790 |
09/08/2003 |
MICROMLC |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K993574 |
10/21/1999 |
OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON |
TOSHIBA AMERICA MRI, INC. |
| K993803 |
11/09/1999 |
EXCELART WITH PIANISSIMO |
TOSHIBA AMERICA MRI, INC. |
| K173759 |
12/11/2017 |
Thermage CPT System and Accessories |
Solta Medical |
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