Cynosure L L C

FDA Filings

This page includes the latest FDA filings for Cynosure L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1222993
• FEI Number: 1000120578
• Name: CYNOSURE, LLC
• Owner & Operator: CYNOSURE, LLC
• Contact Address: 5 CARLISLE ROAD --; Westford MA 01886 US
• Official Correspondent:
  • Kevin - O'Connell
  • 1-978-2564200-4736
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 5 CARLISLE RD ; Westford, MA 01886 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 10841494107908 Cynosure, LLC	ASSY, Probe Kit, 5 PK, TempSure Vitalia	2023-04-04
PMN K223292 Cynosure LLC	TempSure System	2022-11-23
PMN K212891 Cynosure, LLC	TempSure System	2022-03-18
PMN K210226 Cynosure LLC	PicoSure Workstation	2021-03-30
PMN K200241 Cynosure LLC	TempSure System	2020-03-25
PMN K193426 | GEX CYNOSURE, LLC	Elite iQ	2020-03-12
PMN K193426 Cynosure LLC	Elite IQ	2020-03-09
PMN K132665 | GEI CYNOSURE, LLC	PELLEVE GLIDESAFE	2019-12-12
PMN K182741 | PKT CYNOSURE, LLC	Sculpsure, WarmSculpt, Petite Mask	2019-09-07
PMN K182741 | OOK CYNOSURE, LLC	Sculpsure, WarmSculpt, Petite Mask	2019-09-07
PMN K190678 | PBX CYNOSURE, LLC	TempSure System	2019-08-06
PMN K190678 | PBX CYNOSURE, LLC	TempSure Firm	2019-08-06
PMN K190678 | GEI CYNOSURE, LLC	TempSure System	2019-08-06
PMN K190678 | GEI CYNOSURE, LLC	TempSure Firm	2019-08-06
PMN K182365 | GEI CYNOSURE, LLC	TempSure System	2018-12-05
PMN K173199 | GEX CYNOSURE, LLC	PicoSure Laser Workstation, PicoSure Skin	2018-08-20
PMN K171992 | PKT CYNOSURE, LLC	SculpSure	2017-09-27
PMN K171992 | OOK CYNOSURE, LLC	SculpSure	2017-09-27
PMN K171262 | PBX CYNOSURE, LLC	Vitalia	2017-09-27
PMN K171262 | PBX CYNOSURE, LLC	TempSure	2017-09-27
PMN K171262 | GEI CYNOSURE, LLC	Vitalia	2017-09-27
PMN K171262 | GEI CYNOSURE, LLC	TempSure	2017-09-27
ODR CYNOSURE, LLC	Neutral Plate	2017-09-27
PMN K171111 | PKT CYNOSURE, LLC	SculpSure	2017-07-06
PMN K171111 | OOK CYNOSURE, LLC	SculpSure	2017-07-06
PMN K160470 | PKT CYNOSURE, LLC	SculpSure	2016-09-26
PMN K160470 | OOK CYNOSURE, LLC	SculpSure	2016-09-26
PMN K142376 | ONG CYNOSURE, LLC	Icon	2016-09-26
PMN K142376 | GEX CYNOSURE, LLC	Icon	2016-09-26
PMN K141511 | GEX CYNOSURE, LLC	Precision Tx, Side Laze 800 Laser Beam Delivery Accessory	2016-09-26
JEX CYNOSURE, LLC	Non-Slip Grip Tip Pliers	2016-08-29
GAX CYNOSURE, LLC	ELLMAN DIGIT TOURNIQUETS	2016-08-29
EIG CYNOSURE, LLC	Self Span Cheek and Lip Retractors	2016-08-29
PMN K160480 | GEX CYNOSURE, LLC	PicoSure Workstation with 1064 nm Laser Delivery System	2016-07-07
PMN K150724 | PKT CYNOSURE, LLC	SculpSure	2015-09-24
PMN K150230 | PKT CYNOSURE, LLC	SculpSure	2015-09-24
PMN K143105 | GEX CYNOSURE, LLC	PicoSure Workstation with 532 nm Delivery System	2015-06-05
PMN K140719 | GEX CYNOSURE, LLC	PicoSure Skin	2014-11-03
PMN K140719 | GEX CYNOSURE, LLC	PicoSure Laser workstation	2014-11-03
PMN K132949 | PBX CYNOSURE, LLC	PelleFirm	2014-10-07
JOS CYNOSURE, LLC	Sterile Tongue Base Reduction Electrode	2014-10-07
JOS CYNOSURE, LLC	Sterile Sub-Mucosal VTR (UPP) Electrode	2014-10-07
JOS CYNOSURE, LLC	Sterile RF Suction Coagulator	2014-10-07
JOS CYNOSURE, LLC	Sterile RF Angled Suction Coagulator	2014-10-07
JOS CYNOSURE, LLC	Sterile RAUP Electrode	2014-10-07
JOS CYNOSURE, LLC	Sterile MicroInsulated Needles	2014-10-07
JOS CYNOSURE, LLC	Sterile Micro Fibre? Electrode	2014-10-07
JOS CYNOSURE, LLC	Sterile LLETZ Bayonet Electrodes	2014-10-07
JOS CYNOSURE, LLC	Sterile IEC-XBHP3	2014-10-07
JOS CYNOSURE, LLC	Sterile IEC-3FHPB/D	2014-10-07
JOS CYNOSURE, LLC	Sterile Empire Microlncision	2014-10-07
JOS CYNOSURE, LLC	Sterile Dermatology Electrode	2014-10-07
JOS CYNOSURE, LLC	Sterile Clear-Vu? Bayonet Electrodes	2014-10-07
JOS CYNOSURE, LLC	Sterile Beigi Minimally Invasive Entropion Electrode	2014-10-07
JOS CYNOSURE, LLC	Reusable Suction Coagulator Kit (H40)	2014-10-07
JOS CYNOSURE, LLC	Reusable Standard Podiatry Electrodes (S11B)	2014-10-07
JOS CYNOSURE, LLC	Reusable Round Loop Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable Rodin? Microsurgery Handpiece	2014-10-07
JOS CYNOSURE, LLC	Reusable Rhinophyma Electrode Set	2014-10-07
JOS CYNOSURE, LLC	Reusable RF Wedge Resection Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable RF Myringotomy Electrode	2014-10-07
JOS CYNOSURE, LLC	Reusable RF Laparoscopic Handpiece	2014-10-07
JOS CYNOSURE, LLC	Reusable RF Laparoscopic Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable RF Assisted Tonsillotomy (RAT) Ball Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable Patented 1 Button Fingerswitch Handpiece	2014-10-07
JOS CYNOSURE, LLC	Reusable Oval Loop Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable Ophthalmic Micro-Dissection Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable OTO-RAM Radiofrequency Assisted Myringotomy Handpieces (IEC-EE600/IEC-H604)	2014-10-07
JOS CYNOSURE, LLC	Reusable OTO-RAM Probe (1.5mm/2.0mm)	2014-10-07
JOS CYNOSURE, LLC	Reusable Needle Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable MicroInsulated Needle Handpiece	2014-10-07
JOS CYNOSURE, LLC	Reusable MicroInsulated Needle Handpiece with Locking Chuck	2014-10-07
JOS CYNOSURE, LLC	Reusable Micro-Larynx RF Probes (Loop/Needle/Ball)	2014-10-07
JOS CYNOSURE, LLC	Reusable LLETZ Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable LLETZ Bayonet Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable Javate/Khan RF Endoscopic Forehead Suction Probe	2014-10-07
JOS CYNOSURE, LLC	Reusable Javate/Khan Endo Forehead Suction Kit	2014-10-07
JOS CYNOSURE, LLC	Reusable Javate/Khan Coated Spade Suction Probe	2014-10-07
JOS CYNOSURE, LLC	Reusable Javate/Khan Coated Flate Scalpel Suction Probe	2014-10-07
JOS CYNOSURE, LLC	Reusable Javate Endoscopic DCR Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable Insulated Sclerotherapy Needles	2014-10-07
JOS CYNOSURE, LLC	Reusable Insulated Needle Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable Insulated Matrixectomy Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable Giosis RF Elevator	2014-10-07
JOS CYNOSURE, LLC	Reusable Foot-Controlled Handpiece	2014-10-07
JOS CYNOSURE, LLC	Reusable External Genital Lesion RF Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable Empire MicroTip Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable Cryptolysis Electrode	2014-10-07
JOS CYNOSURE, LLC	Reusable Conization Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable Chedly Pucntal Occlusion (CPO) Electrodes	2014-10-07
JOS CYNOSURE, LLC	Reusable Blade Handpiece	2014-10-07
JOS CYNOSURE, LLC	Reusable Baker Brow Probe	2014-10-07
JOS CYNOSURE, LLC	Reusable Adenoid RF Electrode	2014-10-07
JOS CYNOSURE, LLC	Reusable 3" Length Handpiece with Patented Locking Chuck (XLP1)	2014-10-07
JOS CYNOSURE, LLC	Reusable 3" Length Handpiece with Patented Locking Chuck (IEC-XLP1)	2014-10-07
PMN K972072 | GEI CYNOSURE, LLC	Surgitron FFPF EMC	2014-10-06
PMN K964176 | GEI CYNOSURE, LLC	Mono Stan RF Forceps, Bayonet Bipolar Forceps, Bipolar Forceps	2014-10-06
PMN K964176 | GEI CYNOSURE, LLC	Microstan Forceps, Microstan RF Forceps, Mini Mono Stan RF forceps,	2014-10-06
PMN K955176 | EKZ CYNOSURE, LLC	Dento-Surg 90 F.F.P.	2014-10-06
PMN K954718 | HEE CYNOSURE, LLC	Needle Extender/Measured Dose Syringe	2014-10-06
PMN K123366 | GEI CYNOSURE, LLC	Pelleve S5 IEC, Pelleve Gel, Surgitron 4.0 Dual RF S5 IEC	2014-10-06
PMN K102698 | GEI CYNOSURE, LLC	Pelleve Glidesafe Handpiece	2014-10-06
PMN K071343 | GEI CYNOSURE, LLC	RF Suction Adenoid Probes, Noble Alloy Electrodes	2014-10-06
PMN K071343 | GEI CYNOSURE, LLC	Ace-Tip Electrodes, Bayonet Turbinate Electrode, Tonsillectomy Probe,	2014-10-06
PMN K042710 | GEI CYNOSURE, LLC	Acusect, Radiolase II	2014-10-06
PMN K013255 | GEI CYNOSURE, LLC	Surgitron 4.0 Dual RFA/90 IEC, Surgitron 4.0 Dual RFA/120 IEC	2014-10-06
HOY CYNOSURE, LLC	Corneal Shields	2014-10-06
HNI CYNOSURE, LLC	Chedley Eyelid Retractor	2014-10-06
ELR CYNOSURE, LLC	Post Kit	2014-10-06
EKG CYNOSURE, LLC	Silva-Packer	2014-10-06
EJL CYNOSURE, LLC	Roto-Pro, Non-Clogging Bur, Dental Bur	2014-10-06
EBL CYNOSURE, LLC	Nubond Post, Screw	2014-10-06
PMN K141425 | GEX CYNOSURE, LLC	Elite + Laser	2014-09-17
PMN K133364 | GEX CYNOSURE, LLC	PicoSure workstation	2014-09-17
PMN K133364 | GEX CYNOSURE, LLC	PicoSure Skin	2014-09-17
PMN K050382 | GEX CYNOSURE, LLC	Affinity QS	2014-06-13
PMN K123407 | OYW CYNOSURE, LLC	SLT II	2014-05-19
PMN K123407 | OYW CYNOSURE, LLC	Cellulaze	2014-05-19
PMN K053608 | GEX CYNOSURE, LLC	V Star Laser	2014-05-19
PMN K081181 | GEX CYNOSURE, LLC	SmartSkin	2014-04-18
PMN K081181 | GEX CYNOSURE, LLC	SmartSkin+	2014-04-18
PMN K061436 | GEX CYNOSURE, LLC	Q-YAG5 Nd:YAG Laser System	2014-01-30
PMN K090195 | GEX CYNOSURE, LLC	Lux 1540 HP	2014-01-28
PMN K020453 | GEX CYNOSURE, LLC	MediLux	2014-01-27
PMN K020453 | GEX CYNOSURE, LLC	EsteLux	2014-01-27
PMN K083165 | GEX CYNOSURE, LLC	Aspire	2014-01-08
PMN K041086 | GEX CYNOSURE, LLC	StarLux 500	2014-01-08
PMN K041086 | GEX CYNOSURE, LLC	StarLux 300	2014-01-08
PMN K111840 | ONG CYNOSURE, LLC	Emerge	2013-10-21
PMN K110907 | ONG CYNOSURE, LLC	Icon	2013-10-21
PMN K110907 | GEX CYNOSURE, LLC	Icon	2013-10-21
PMN K101506 | ONG CYNOSURE, LLC	Lux 2940	2013-10-21
PMN K101506 | ONG CYNOSURE, LLC	Lux 1540	2013-10-21
PMN K101506 | ONG CYNOSURE, LLC	Lux 1440	2013-10-21
PMN K101415 | GEX CYNOSURE, LLC	Theraclear	2013-10-21
PMN K100270 | GEX CYNOSURE, LLC	Artisan	2013-10-21
PMN K083455 | MUU CYNOSURE, LLC	Adivive	2013-10-21
PMN K033549 | GEX CYNOSURE, LLC	Starlux 500	2013-10-21
PMN K120622 | GEX CYNOSURE, LLC	Vectus	2013-08-05
PMN K121346 | GEX CYNOSURE, LLC	PicoSure	2013-03-01
PMN K121346 | GEX CYNOSURE, LLC	PicoSure Skin	2013-03-01
PMN K121127 | GEX CYNOSURE, LLC	SideLaze800	2012-08-24
PMN K121127 | GEX CYNOSURE, LLC	PrecisionTX	2012-08-24
PMN K102541 | OYW CYNOSURE, LLC	Cellulaze laser, SLT II	2012-02-22
PMN K090618 | GEX CYNOSURE, LLC	SmartCool	2011-11-18
PMN K090618 | GEX CYNOSURE, LLC	Cryo 6, Cryo-C	2011-11-18
PMN K103118 | GEX CYNOSURE, LLC	RevLite SI	2011-11-16
PMN K063112 | GEX CYNOSURE, LLC	RevLite	2011-08-01
PMN K014234 | GEX CYNOSURE, LLC	MedLite C6	2011-08-01
PMN K100230 | NUV CYNOSURE, LLC	SmoothShapes XV System and the Petite Photomology Module	2011-02-07
PMN K083629 | NUV CYNOSURE, LLC	SmoothShapes System	2011-02-07
PMN K101601 | GEX CYNOSURE, LLC	Affirm DO	2010-12-13
PMN K091537 | GEX CYNOSURE, LLC	SmartLipo Triplex	2009-11-16
PMN K091537 | GEX CYNOSURE, LLC	SLT II	2009-11-16
PMN K091537 | GEX CYNOSURE, LLC	Precision Tx	2009-11-16
PMN K091169 | GEX CYNOSURE, LLC	Elite MPX	2009-11-16
PMN K083795 | GEX CYNOSURE, LLC	SmartLipo MPX	2009-11-16
PMN K081424 | GEX CYNOSURE, LLC	SmartSkin+	2009-05-18
PMN K081424 | GEX CYNOSURE, LLC	SmartSkin CO2	2009-05-18
PMN K081424 | GEX CYNOSURE, LLC	Affirm CO2 Laser / Performa	2009-05-18
PMN K030876 | ISA CYNOSURE, LLC	TriActive Workstation	2008-10-07
PMN K072868 | GEX CYNOSURE, LLC	Accolade Laser	2007-12-14
PMN K070063 | GEX CYNOSURE, LLC	Affirm Laser	2007-12-14
PMN K062321 | GEX CYNOSURE, LLC	SmartLipo Laser	2007-12-14
PMN K050779 | GEX CYNOSURE, LLC	Cynergy Laser	2007-12-14
PMN K034030 | GEX CYNOSURE, LLC	Elite Laser	2007-12-14
PMN K032539 | GEX CYNOSURE, LLC	PhotoGenica SV Laser	2007-12-14
PMN K031488 | GEX CYNOSURE, LLC	Apogee Laser	2007-12-14
PMN K031258 | GEX CYNOSURE, LLC	Cynergy PL	2007-12-14
PMN K011828 | GEX CYNOSURE, LLC	Acclaim Laser	2007-12-14
PMN K000490 | GEX CYNOSURE, LLC	V Star Laser	2007-12-14

Related Finance Registrations

NCAGE Code	8D8A6	CYNOSURE, LLC
NCAGE Code	7LK01	CYNOSURE LLC
CAGE Code	8D8A6	CYNOSURE, LLC
CAGE Code	7LK01	CYNOSURE LLC
S.A.M. Registration	8D8A6 [117116309]	CYNOSURE, LLC
DUNS	117116309	CynoSure, LLC
DUNS	079814370	Cynosure LLC