FDA 510(k) Applications Submitted by A WORDEN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K072699 |
09/24/2007 |
ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL |
ALMA LASERS LTD. |
| K083215 |
10/31/2008 |
INCISIVE FAMILY OF INPULSE ND:YAG LASERS |
INCISIVE, LLC. |
| K030147 |
01/15/2003 |
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS |
LUMENIS, LTD. |
| K960032 |
01/02/1996 |
COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS |
COHERENT MEDICAL GROUP |
| K030033 |
01/03/2003 |
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES |
LUMENIS, LTD. |
| K070004 |
01/03/2007 |
ACCENT |
ALMA LASERS LTD. |
| K040010 |
01/05/2004 |
GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS |
GENESIS MEDICAL INTERVENTIONAL, INC. |
| K980079 |
01/09/1998 |
COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES |
LUMENIS, INC. |
| K000122 |
01/18/2000 |
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX) |
NEUCOLL, INC. |
| K960413 |
01/29/1996 |
COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT |
LUMENIS, INC. |
| K090281 |
02/05/2009 |
ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES |
ACCUTECH MEDICAL TECHNOLOGIES, INC. |
| K080463 |
02/20/2008 |
ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES |
ALMA LASERS LTD. |
| K980685 |
02/23/1998 |
MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS |
LUMENIS, INC. |
| K061025 |
04/13/2006 |
ACCUTECH ENDOLITE PROBE |
ACCUTECH MEDICAL TECHNOLOGIES, INC. |
| K091323 |
05/05/2009 |
MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) |
INTERMEDIC ARFRAN, S.A. |
| K972347 |
06/24/1997 |
MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER |
LUMENIS, INC. |
| K022060 |
06/25/2002 |
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES |
LUMENIS, INC. |
| K112031 |
07/15/2011 |
ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION |
ALMA LASERS, INC. |
| K062048 |
07/20/2006 |
AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM |
AESTHERA CORPORATION |
| K042000 |
07/26/2004 |
MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS |
MSQ (M2) LTD. |
| K072182 |
08/06/2007 |
ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060 |
ALMA LASERS LTD. |
| K963339 |
08/26/1996 |
COHERENT ULTRAPULSE CO2 SURGICAL LASERS |
COHERENT MEDICAL GROUP |
| K092623 |
08/26/2009 |
F.A.S.T. SYSTEM SED AND CXD |
GENESIS MEDICAL INTERVENTIONAL, INC. |
| K082622 |
09/09/2008 |
ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE |
ALMA LASERS LTD. |
| K072564 |
09/11/2007 |
ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM |
ALMA LASERS LTD. |
| K023050 |
09/13/2002 |
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI |
RELIANT TECHNOLOGIES, INC. |
| K093545 |
11/17/2009 |
PINPOINTE FOOTLASER MODEL 6W, 30W, 100W |
INCISIVE, INC. (FORMERLY NAMED INCISIVE, LLC) |
| K093547 |
11/17/2009 |
PINPOINTE FOOTLASER |
PINPOINTE USA, INC. |
| K113585 |
12/05/2011 |
NASAL/EPISTAXIS PACK |
COGENT THERAPEUTICS, LLC |
| K083616 |
12/08/2008 |
PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS |
PATHOLASE, INC |
| K024093 |
12/11/2002 |
MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS |
LUMENIS, LTD. |
| K033946 |
12/19/2003 |
LOVELY SYSTEM |
MSQ (M2) LTD. |
| K052435 |
09/06/2005 |
PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS |
PNEUMRX, INC. |
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