Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cynosure, Inc. · Predicate Candidate Screening
98 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
207 days90th percentile
98clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190678 | TempSure | Cynosure, Inc. | 2019-07-24 | 128 | 0 |
| K182365 | TempSure System | Cynosure, Inc. | 2018-10-24 | 55 | 0 |
| K173199 | PicoSure Workstation | Cynosure, Inc. | 2018-02-07 | 128 | 0 |
| K171992 | SculpSure | Cynosure, Inc. | 2017-09-26 | 85 | 0 |
| K171262 | TempSure | Cynosure, Inc. | 2017-09-22 | 144 | 0 |
| K171111 | Sculpsure | Cynosure, Inc. | 2017-06-13 | 60 | 0 |
| K160470 | SculpSure | Cynosure, Inc. | 2016-07-21 | 153 | 0 |
| K160480 | PicoSure Workstation | Cynosure, Inc. | 2016-05-17 | 85 | 0 |
| K150724 | SculpSure | Cynosure, Inc. | 2015-07-01 | 103 | 0 |
| K150230 | SculpSure | Cynosure, Inc. | 2015-05-15 | 102 | 0 |
| K143105 | Picosure Workstation | Cynosure, Inc. | 2015-02-23 | 117 | 0 |
| K141511 | SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440M | Cynosure, Inc. | 2015-01-23 | 228 | 0 |
| K142376 | Palomar Icon Aesthetic System | Cynosure, Inc. | 2014-09-24 | 29 | 0 |
| K140719 | PICOSURE WORKSTATION | Cynosure, Inc. | 2014-09-22 | 185 | 0 |
| K141425 | ELITE + LASER SYSTEM | Cynosure, Inc. | 2014-09-11 | 104 | 0 |
| K133364 | PICOSURE WORKSTATION | Cynosure, Inc. | 2014-07-22 | 263 | 0 |
| K133254 | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM | Cynosure, Inc. | 2014-03-05 | 134 | 0 |
| K133473 | ILUMINAGE SKIN SMOOTHING LASER | Cynosure, Inc. | 2014-01-15 | 64 | 0 |
| K123971 | CYNOSURE 1064NM DIODE LASER | Cynosure, Inc. | 2013-05-02 | 127 | 0 |
| K123407 | CELLULAZE LASER | Cynosure, Inc. | 2013-03-29 | 144 | 0 |
| K121346 | PICOSURE WORKSTATION | Cynosure, Inc. | 2012-11-27 | 207 | 0 |
| K111454 | ILUMINAGE DIODE LASER | Cynosure, Inc. | 2012-07-05 | 407 | 0 |
| K121127 | SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM W | Cynosure, Inc. | 2012-05-13 | 30 | 0 |
| K102541 | CYNOSURE CELLULAZE LASER | Cynosure, Inc. | 2012-01-26 | 510 | 0 |
| K111901 | ASA 'MPHI FAMILY DIODE LASER | Cynosure, Inc. | 2011-11-09 | 127 | 0 |
| K101601 | AFFIRM DO DIODE LASER | Cynosure, Inc. | 2010-09-23 | 107 | 0 |
| K091537 | CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELEN | Cynosure, Inc. | 2009-09-03 | 100 | 0 |
| K091169 | ELITE MPX LASER SYSTEM WITH CRYO C | Cynosure, Inc. | 2009-05-13 | 21 | 1 |
| K090618 | CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTC | Cynosure, Inc. | 2009-04-14 | 36 | 0 |
| K081424 | AFFIRM CO2 AND AFFIRM CO2 HP | Cynosure, Inc. | 2009-03-19 | 303 | 0 |
| K090235 | ELITE MPX LASER SYSTEM WITH XPL HANDPIECE | Cynosure, Inc. | 2009-03-17 | 43 | 0 |
| K083795 | CYNOSURE SMARTLIPO MPX LASER | Cynosure, Inc. | 2009-01-21 | 30 | 0 |
| K083379 | CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE | Cynosure, Inc. | 2008-12-12 | 28 | 0 |
| K081181 | SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIO | Cynosure, Inc. | 2008-05-05 | 10 | 0 |
| K080006 | AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE | Cynosure, Inc. | 2008-02-28 | 57 | 0 |
| K080121 | CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER | Cynosure, Inc. | 2008-01-31 | 14 | 0 |
| K072484 | CYNOSURE YAG FAMILY LASER | Cynosure, Inc. | 2007-12-27 | 114 | 0 |
| K073394 | SMARTLIPO LASER | Cynosure, Inc. | 2007-12-12 | 9 | 0 |
| K072868 | ACCOLADE II LASER | Cynosure, Inc. | 2007-11-05 | 27 | 0 |
| K070063 | YAG MIR II LASER | Cynosure, Inc. | 2007-01-30 | 25 | 0 |
| K062321 | SMARTLIPO ND:YAG LASER | Cynosure, Inc. | 2006-10-31 | 83 | 0 |
| K051442 | PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT | Cynosure, Inc. | 2006-05-24 | 356 | 0 |
| K053608 | CYNOSURE PHOTOGENICA V-STAR LASER | Cynosure, Inc. | 2006-02-13 | 48 | 0 |
| K053421 | YAG MIR FAMILY LASER | Cynosure, Inc. | 2006-02-01 | 55 | 0 |
| K051537 | HILT FAMILY LASER: HILT I, HILT II, HILT III | Cynosure, Inc. | 2005-09-26 | 108 | 0 |
| K050382 | AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM | Cynosure, Inc. | 2005-09-14 | 211 | 0 |
| K051922 | ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6 | Cynosure, Inc. | 2005-09-14 | 61 | 0 |
| K050779 | CYNERGY MULTIPLEX LASER | Cynosure, Inc. | 2005-06-27 | 91 | 0 |
| K050080 | CYNOSUREA ECLILITE AND ECLILITE U | Cynosure, Inc. | 2005-05-05 | 112 | 0 |
| K043429 | CYNERGY LASER | Cynosure, Inc. | 2005-01-12 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda