Company ยท US
Cynosure, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2026. Name variants (Inc, Corp, punctuation) are merged.
107510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 85 |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 |
| ILY | Lamp, Infrared, Therapeutic Heating | 4 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 2 |
| OYW | Laser, Cellulite Appearance | 2 |
| FTC | Light, Ultraviolet, Dermatological | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 |
| ISA | Massager, Therapeutic, Electric | 1 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 17, 2026 | K261570 | PICOSURE WORKSTATION Cynosure, LLC | GEX |
| Mar 8, 2024 | K240396 | Elite iQ PRO (M122K1) Cynosure, LLC | GEX |
| Jul 6, 2023 | K230510 | MyEllevate Cynosure, LLC | GAT |
| Nov 23, 2022 | K223292 | TempSure System Cynosure, LLC | GEI |
| Mar 18, 2022 | K212891 | TempSure System Cynosure, LLC | GEI |
| Mar 30, 2021 | K210226 | PicoSure Workstation Cynosure, LLC | GEX |
| Mar 25, 2020 | K200241 | TempSure System Cynosure, LLC | PBX |
| Mar 9, 2020 | K193426 | Elite iQ Cynosure, LLC | GEX |
| Jul 24, 2019 | K190678 | TempSure Cynosure, Inc. | GEI |
| Jan 3, 2019 | K182741 | SculpSure Cynosure | PKT |
| Oct 24, 2018 | K182365 | TempSure System Cynosure, Inc. | GEI |
| Feb 7, 2018 | K173199 | PicoSure Workstation Cynosure, Inc. | GEX |
| Sep 26, 2017 | K171992 | SculpSure Cynosure, Inc. | PKT |
| Sep 22, 2017 | K171262 | TempSure Cynosure, Inc. | GEI |
| Jun 13, 2017 | K171111 | Sculpsure Cynosure, Inc. | PKT |
| Jul 21, 2016 | K160470 | SculpSure Cynosure, Inc. | PKT |
| May 17, 2016 | K160480 | PicoSure Workstation Cynosure, Inc. | GEX |
| Jul 1, 2015 | K150724 | SculpSure Cynosure, Inc. | PKT |
| May 15, 2015 | K150230 | SculpSure Cynosure, Inc. | PKT |
| Feb 23, 2015 | K143105 | Picosure Workstation Cynosure, Inc. | GEX |
| Jan 23, 2015 | K141511 | SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS Cynosure, Inc. | GEX |
| Sep 24, 2014 | K142376 | Palomar Icon Aesthetic System Cynosure, Inc. | GEX |
| Sep 22, 2014 | K140719 | PICOSURE WORKSTATION Cynosure, Inc. | GEX |
| Sep 11, 2014 | K141425 | ELITE + LASER SYSTEM Cynosure, Inc. | GEX |
| Jul 22, 2014 | K133364 | PICOSURE WORKSTATION Cynosure, Inc. | GEX |
| Mar 5, 2014 | K133254 | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM Cynosure, Inc. | GEX |
| Jan 15, 2014 | K133473 | ILUMINAGE SKIN SMOOTHING LASER Cynosure, Inc. | OHS |
| May 2, 2013 | K123971 | CYNOSURE 1064NM DIODE LASER Cynosure, Inc. | ILY |
| Mar 29, 2013 | K123407 | CELLULAZE LASER Cynosure, Inc. | OYW |
| Nov 27, 2012 | K121346 | PICOSURE WORKSTATION Cynosure, Inc. | GEX |
| Jul 5, 2012 | K111454 | ILUMINAGE DIODE LASER Cynosure, Inc. | OHS |
| May 13, 2012 | K121127 | SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS Cynosure, Inc. | GEX |
| Jan 26, 2012 | K102541 | CYNOSURE CELLULAZE LASER Cynosure, Inc. | OYW |
| Nov 9, 2011 | K111901 | ASA 'MPHI FAMILY DIODE LASER Cynosure, Inc. | ILY |
| Sep 23, 2010 | K101601 | AFFIRM DO DIODE LASER Cynosure, Inc. | GEX |
| Sep 3, 2009 | K091537 | CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH Cynosure, Inc. | GEX |
| May 13, 2009 | K091169 | ELITE MPX LASER SYSTEM WITH CRYO C Cynosure, Inc. | GEX |
| Apr 14, 2009 | K090618 | CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C Cynosure, Inc. | GEX |
| Mar 19, 2009 | K081424 | AFFIRM CO2 AND AFFIRM CO2 HP Cynosure, Inc. | GEX |
| Mar 17, 2009 | K090235 | ELITE MPX LASER SYSTEM WITH XPL HANDPIECE Cynosure, Inc. | GEX |
| Jan 21, 2009 | K083795 | CYNOSURE SMARTLIPO MPX LASER Cynosure, Inc. | GEX |
| Dec 12, 2008 | K083379 | CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE Cynosure, Inc. | GEX |
| May 5, 2008 | K081181 | SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER Cynosure, Inc. | GEX |
| Feb 28, 2008 | K080006 | AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE Cynosure, Inc. | GEX |
| Jan 31, 2008 | K080121 | CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER Cynosure, Inc. | GEX |
| Dec 27, 2007 | K072484 | CYNOSURE YAG FAMILY LASER Cynosure, Inc. | GEX |
| Dec 12, 2007 | K073394 | SMARTLIPO LASER Cynosure, Inc. | GEX |
| Nov 5, 2007 | K072868 | ACCOLADE II LASER Cynosure, Inc. | GEX |
| Jan 30, 2007 | K070063 | YAG MIR II LASER Cynosure, Inc. | GEX |
| Oct 31, 2006 | K062321 | SMARTLIPO ND:YAG LASER Cynosure, Inc. | GEX |
Newest 50 of 107.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2014 | Cynosure, Inc. Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System Terminated |
GEX | K091169 |