Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

100 results for "Cynosure, Inc."
1–24 of 100
Search insights Median review: 89d Cleared: 100% Top manufacturer: Cynosure, Inc. Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2025
eCO2 3D
K244060 · ONG
Lutronic Corporation
General & Plastic Surgery · 212d
Cleared Jul 24, 2019
TempSure
K190678 · GEI
Cynosure, Inc.
General & Plastic Surgery · 128d
Cleared Oct 24, 2018
TempSure System
K182365 · GEI
Cynosure, Inc.
General & Plastic Surgery · 55d
Cleared Feb 07, 2018
PicoSure Workstation
K173199 · GEX
Cynosure, Inc.
General & Plastic Surgery · 128d
Cleared Sep 26, 2017
SculpSure
K171992 · PKT
Cynosure, Inc.
General & Plastic Surgery · 85d
Cleared Sep 22, 2017
TempSure
K171262 · GEI
Cynosure, Inc.
General & Plastic Surgery · 144d
Cleared Jun 13, 2017
Sculpsure
K171111 · PKT
Cynosure, Inc.
General & Plastic Surgery · 60d
Cleared Jul 21, 2016
SculpSure
K160470 · PKT
Cynosure, Inc.
General & Plastic Surgery · 153d
Cleared May 17, 2016
PicoSure Workstation
K160480 · GEX
Cynosure, Inc.
General & Plastic Surgery · 85d
Cleared Jul 21, 2015
Cortex Laser System
K150587 · GEX
Cynosure, Inc. Dba Ellman
General & Plastic Surgery · 134d
Cleared Jul 01, 2015
SculpSure
K150724 · PKT
Cynosure, Inc.
General & Plastic Surgery · 103d
Cleared May 15, 2015
SculpSure
K150230 · PKT
Cynosure, Inc.
General & Plastic Surgery · 102d
Cleared Feb 23, 2015
Picosure Workstation
K143105 · GEX
Cynosure, Inc.
General & Plastic Surgery · 117d
Cleared Jan 23, 2015
SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
K141511 · GEX
Cynosure, Inc.
General & Plastic Surgery · 228d
Cleared Sep 24, 2014
Palomar Icon Aesthetic System
K142376 · GEX
Cynosure, Inc.
General & Plastic Surgery · 29d
Cleared CT Sep 22, 2014
PICOSURE WORKSTATION
K140719 · GEX
Cynosure, Inc.
General & Plastic Surgery · 185d
Cleared Sep 11, 2014
ELITE + LASER SYSTEM
K141425 · GEX
Cynosure, Inc.
General & Plastic Surgery · 104d
Cleared Jul 22, 2014
PICOSURE WORKSTATION
K133364 · GEX
Cynosure, Inc.
General & Plastic Surgery · 263d
Cleared Mar 05, 2014
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
K133254 · GEX
Cynosure, Inc.
General & Plastic Surgery · 134d
Cleared Jan 15, 2014
ILUMINAGE SKIN SMOOTHING LASER
K133473 · OHS
Cynosure, Inc.
General & Plastic Surgery · 64d
Cleared May 02, 2013
CYNOSURE 1064NM DIODE LASER
K123971 · ILY
Cynosure, Inc.
Physical Medicine · 127d
Cleared Mar 29, 2013
CELLULAZE LASER
K123407 · OYW
Cynosure, Inc.
General & Plastic Surgery · 144d
Cleared Nov 27, 2012
PICOSURE WORKSTATION
K121346 · GEX
Cynosure, Inc.
General & Plastic Surgery · 207d
Cleared Jul 05, 2012
ILUMINAGE DIODE LASER
K111454 · OHS
Cynosure, Inc.
General & Plastic Surgery · 407d