Medical Device Manufacturer · US , Bedford , MA

Cynosure, Inc. - FDA 510(k) Cleared Devices

98 submissions · 98 cleared · Since 1992
98
Total
98
Cleared
0
Denied
93 devices
26-50 of 93
Cleared May 13, 2009
ELITE MPX LASER SYSTEM WITH CRYO C
K091169 · GEX
General & Plastic Surgery · 21d
Cleared Apr 14, 2009
CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
K090618 · GEX
General & Plastic Surgery · 36d
Cleared Mar 19, 2009
AFFIRM CO2 AND AFFIRM CO2 HP
K081424 · GEX
General & Plastic Surgery · 303d
Cleared Mar 17, 2009
ELITE MPX LASER SYSTEM WITH XPL HANDPIECE
K090235 · GEX
General & Plastic Surgery · 43d
Cleared Jan 21, 2009
CYNOSURE SMARTLIPO MPX LASER
K083795 · GEX
General & Plastic Surgery · 30d
Cleared Dec 12, 2008
CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE
K083379 · GEX
General & Plastic Surgery · 28d
Cleared May 05, 2008
SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL...
K081181 · GEX
General & Plastic Surgery · 10d
Cleared Feb 28, 2008
AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE
K080006 · GEX
General & Plastic Surgery · 57d
Cleared Jan 31, 2008
CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER
K080121 · GEX
General & Plastic Surgery · 14d
Cleared Dec 27, 2007
CYNOSURE YAG FAMILY LASER
K072484 · GEX
General & Plastic Surgery · 114d
Cleared Dec 12, 2007
SMARTLIPO LASER
K073394 · GEX
General & Plastic Surgery · 9d
Cleared Nov 05, 2007
ACCOLADE II LASER
K072868 · GEX
General & Plastic Surgery · 27d
Cleared Jan 30, 2007
YAG MIR II LASER
K070063 · GEX
General & Plastic Surgery · 25d
Cleared Oct 31, 2006
SMARTLIPO ND:YAG LASER
K062321 · GEX
General & Plastic Surgery · 83d
Cleared May 24, 2006
PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT
K051442 · GEX
General & Plastic Surgery · 356d
Cleared Feb 13, 2006
CYNOSURE PHOTOGENICA V-STAR LASER
K053608 · GEX
General & Plastic Surgery · 48d
Cleared Feb 01, 2006
YAG MIR FAMILY LASER
K053421 · GEX
General & Plastic Surgery · 55d
Cleared Sep 14, 2005
AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM
K050382 · GEX
General & Plastic Surgery · 211d
Cleared Jun 27, 2005
CYNERGY MULTIPLEX LASER
K050779 · GEX
General & Plastic Surgery · 91d
Cleared May 05, 2005
CYNOSUREA ECLILITE AND ECLILITE U
K050080 · FTC
General & Plastic Surgery · 112d
Cleared Jan 12, 2005
CYNERGY LASER
K043429 · GEX
General & Plastic Surgery · 30d
Cleared May 26, 2004
PHOTOSILK PULSED LIGHT SYSTEM
K041095 · GEX
General & Plastic Surgery · 29d
Cleared Apr 30, 2004
SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER
K040289 · GEX
General & Plastic Surgery · 84d
Cleared Feb 09, 2004
APOGEE ELITE
K034030 · GEX
General & Plastic Surgery · 42d
Cleared Jan 21, 2004
TRISTAR AESTHETIC WORKSTATION LASER
K033176 · GEX
General & Plastic Surgery · 112d

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