FDA 510(k) Applications Submitted by Jeffrey Roberts
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100352 |
02/12/2010 |
DIAGNOSOFT HARP MODEL 2.06 |
DIAGNOSOFT, INC. |
| K140466 |
02/24/2014 |
PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 |
ST. JUDE MEDICAL SYSTEMS AB |
| K111342 |
05/13/2011 |
LIGHT GUIDE CABLE |
SCHOTT NORTH AMERICA |
| K111450 |
05/25/2011 |
MIROCAM CAPSULE ENDOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
| K071469 |
05/29/2007 |
INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM |
CANDELA CORP. |
| K141453 |
06/02/2014 |
ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER |
LIGHTLAB IMAGING, INC. |
| K111833 |
06/28/2011 |
VIRTUE |
DIAGNOSOFT, INC. |
| K141769 |
07/01/2014 |
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER |
LIGHTLAB IMAGING, INC. |
| K232827 |
09/13/2023 |
LightForce Orthodontic System |
LightForce Orthodontics |
| K063074 |
10/06/2006 |
CANDELA 3630 LASER SYSTEM |
CANDELA CORP. |
| K123369 |
11/01/2012 |
ILUMIEN OPTIS |
LIGHTLAB IMAGING, INC. |
| K063800 |
12/22/2006 |
CANDELA FLUORESCENT PULSED LIGHT SYSTEM |
CANDELA CORP. |
| K083458 |
11/21/2008 |
INTRAMEDULLARY FIXATION ROD (IFS) |
NOVALIGN ORTHOPAEDICS, INC |
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