Medical Device Manufacturer · US , Bedford , MA

Cynosure, Inc.

98 submissions · 98 cleared · Since 1992
98
Total
98
Cleared
0
Denied

Cynosure, Inc. — FDA 510(k) Submissions

Cynosure, Inc. has submitted 98 FDA 510(k) premarket notifications since 1992, of which 98 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Powered Laser Surgical Instrument, Laser For Disruption Of Adipocyte Cells For Aesthetic Use, Lamp, Infrared, Therapeutic Heating, Electrosurgical, Cutting & Coagulation & Accessories, Laser, Cellulite Appearance . Use the specialty filter in the sidebar to narrow results.

98 devices
1–25 of 98
TempSure
K190678 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jul 2019 128d
TempSure System
K182365 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2018 55d
PicoSure Workstation
K173199 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 2018 128d
SculpSure
K171992 · PKT Laser For Disruption Of... · General & Plastic Surgery
Sep 2017 85d
TempSure
K171262 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 2017 144d
Sculpsure
K171111 · PKT Laser For Disruption Of... · General & Plastic Surgery
Jun 2017 60d
SculpSure
K160470 · PKT Laser For Disruption Of... · General & Plastic Surgery
Jul 2016 153d
PicoSure Workstation
K160480 · GEX Powered Laser Surgical... · General & Plastic Surgery
May 2016 85d
SculpSure
K150724 · PKT Laser For Disruption Of... · General & Plastic Surgery
Jul 2015 103d
SculpSure
K150230 · PKT Laser For Disruption Of... · General & Plastic Surgery
May 2015 102d
Picosure Workstation
K143105 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 2015 117d
SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
K141511 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jan 2015 228d
Palomar Icon Aesthetic System
K142376 · GEX Powered Laser Surgical... · General & Plastic Surgery
Sep 2014 29d
PICOSURE WORKSTATION
K140719 · GEX Powered Laser Surgical... · General & Plastic Surgery
Sep 2014 185d
ELITE + LASER SYSTEM
K141425 · GEX Powered Laser Surgical... · General & Plastic Surgery
Sep 2014 104d
PICOSURE WORKSTATION
K133364 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jul 2014 263d
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
K133254 · GEX Powered Laser Surgical... · General & Plastic Surgery
Mar 2014 134d
ILUMINAGE SKIN SMOOTHING LASER
K133473 · OHS Light Based Over The... · General & Plastic Surgery
Jan 2014 64d
CYNOSURE 1064NM DIODE LASER
K123971 · ILY Lamp, Infrared,... · Physical Medicine
May 2013 127d
CELLULAZE LASER
K123407 · OYW Laser, Cellulite Appearance · General & Plastic Surgery
Mar 2013 144d
PICOSURE WORKSTATION
K121346 · GEX Powered Laser Surgical... · General & Plastic Surgery
Nov 2012 207d
ILUMINAGE DIODE LASER
K111454 · OHS Light Based Over The... · General & Plastic Surgery
Jul 2012 407d
SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
K121127 · GEX Powered Laser Surgical... · General & Plastic Surgery
May 2012 30d
CYNOSURE CELLULAZE LASER
K102541 · OYW Laser, Cellulite Appearance · General & Plastic Surgery
Jan 2012 510d
ASA 'MPHI FAMILY DIODE LASER
K111901 · ILY Lamp, Infrared,... · Physical Medicine
Nov 2011 127d

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