510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Cynosure, LLC

Westford, MA, US

CYNOSURE, LLC appears in FDA device records in Westford, MA. FDA records list 107 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
107
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

Showing 50 of 107

FDA records hold 107 510(k) clearances for Cynosure, LLC between 1992 and 2026. The busiest year on record is 2003, with 10. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Cynosure, LLC, by decision year
YearClearances
19925
19941
19951
19963
19975
19983
19994
20004
20015
20022
200310
20045
20056
20064
20074
20084
20096
20101
20111
20124
20132
20146
20154
20162
20173
20182
20192
20202
20211
20222
20231
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261570PICOSURE WORKSTATIONGEXSubstantially Equivalent
K240396Elite iQ PRO (M122K1)GEXSubstantially Equivalent
K230510MyEllevateGATSubstantially Equivalent
K223292TempSure SystemGEISubstantially Equivalent
K212891TempSure SystemGEISubstantially Equivalent
K210226PicoSure WorkstationGEXSubstantially Equivalent
K200241TempSure SystemPBXSubstantially Equivalent
K193426Elite iQGEXSubstantially Equivalent
K190678TempSureGEISubstantially Equivalent
K182741SculpSurePKTSubstantially Equivalent
K182365TempSure SystemGEISubstantially Equivalent
K173199PicoSure WorkstationGEXSubstantially Equivalent
K171992SculpSurePKTSubstantially Equivalent
K171262TempSureGEISubstantially Equivalent
K171111SculpsurePKTSubstantially Equivalent
K160470SculpSurePKTSubstantially Equivalent
K160480PicoSure WorkstationGEXSubstantially Equivalent
K150724SculpSurePKTSubstantially Equivalent
K150230SculpSurePKTSubstantially Equivalent
K143105Picosure WorkstationGEXSubstantially Equivalent
K141511SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERSGEXSubstantially Equivalent
K142376Palomar Icon Aesthetic SystemGEXSubstantially Equivalent
K140719PICOSURE WORKSTATIONGEXSubstantially Equivalent
K141425ELITE + LASER SYSTEMGEXSubstantially Equivalent
K133364PICOSURE WORKSTATIONGEXSubstantially Equivalent
K133254REVLITE Q-SWITCHED ND:YAG LASER SYSTEMGEXSubstantially Equivalent
K133473ILUMINAGE SKIN SMOOTHING LASEROHSSubstantially Equivalent
K123971CYNOSURE 1064NM DIODE LASERILYSubstantially Equivalent
K123407CELLULAZE LASEROYWSubstantially Equivalent
K121346PICOSURE WORKSTATIONGEXSubstantially Equivalent
K111454ILUMINAGE DIODE LASEROHSSubstantially Equivalent
K121127SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERSGEXSubstantially Equivalent
K102541CYNOSURE CELLULAZE LASEROYWSubstantially Equivalent
K111901ASA 'MPHI FAMILY DIODE LASERILYSubstantially Equivalent
K101601AFFIRM DO DIODE LASERGEXSubstantially Equivalent
K091537CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTHGEXSubstantially Equivalent
K091169ELITE MPX LASER SYSTEM WITH CRYO CGEXSubstantially Equivalent
K090618CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO CGEXSubstantially Equivalent
K081424AFFIRM CO2 AND AFFIRM CO2 HPGEXSubstantially Equivalent
K090235ELITE MPX LASER SYSTEM WITH XPL HANDPIECEGEXSubstantially Equivalent
K083795CYNOSURE SMARTLIPO MPX LASERGEXSubstantially Equivalent
K083379CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULEGEXSubstantially Equivalent
K081181SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASERGEXSubstantially Equivalent
K080006AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULEGEXSubstantially Equivalent
K080121CYNOSURE SMARTLIPO MULTIWAVLENGTH LASERGEXSubstantially Equivalent
K072484CYNOSURE YAG FAMILY LASERGEXSubstantially Equivalent
K073394SMARTLIPO LASERGEXSubstantially Equivalent
K072868ACCOLADE II LASERGEXSubstantially Equivalent
K070063YAG MIR II LASERGEXSubstantially Equivalent
K062321SMARTLIPO ND:YAG LASERGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Cynosure, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12229931000120578CYNOSURE, LLC5 CARLISLE RD, Westford, MA 01886 US2026and 13 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0169-2015Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser SystemIf the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shockClass IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain