Cynosure, LLC

Country / region:United States (US)

510(k) submissions

Latest clearance

2024-03-08

Product codes

GEX

Cited as predicate

Product areas

FDA product code distribution

7 total

K number	Device name	Product code	Class	Decision date
K240396	Elite iQ PRO (M122K1)	GEX	Class 2	2024-03-08
K210226	PicoSure Workstation	GEX	Class 2	2021-03-30
K193426	Elite iQ	GEX	Class 2	2020-03-09
K173199	PicoSure Workstation	GEX	Class 2	2018-02-07
K160480	PicoSure Workstation	GEX	Class 2	2016-05-17
K143105	Picosure Workstation	GEX	Class 2	2015-02-23
K141511	SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS	GEX	Class 2	2015-01-23

K233090
—
—
Not ingested
K193426
—
—
Not ingested
K121346
—
—
Not ingested
K133254
—
—
Not ingested
K173199
—
—
Not ingested
K120622
—
—
Not ingested
K141425
—
—
Not ingested
K150516
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
El.En Electronic Engineering Spa
K133254
—
—
Not ingested
K160480
—
—
Not ingested
K133254
—
—
Not ingested
K143105
—
—
Not ingested
K133254
—
—
Not ingested
K140719
—
—
Not ingested
K141305
—
—
Not ingested
K103014
—
—
Not ingested
K121127
—
—
Not ingested

Cynosure, LLC references 17 predicate/reference devices

K260307
Diode Laser Therapy Systems (V19)
Weifang Mingliang Electronics Co., Ltd.
K252369
Boston Pico755
Boston Aesthetics, Inc.
Not ingested
K243957
PICOALEX
Wontech Co., Ltd.
Not ingested
K240396
Elite iQ PRO (M122K1)
Cynosure, LLC
Not ingested
K210226
PicoSure Workstation
Cynosure, LLC
Not ingested
K210168
Diode Laser Therapy Systems
Beijing Kes Biology Technology Co., Ltd.
Not ingested
K202848
S2 Pigment Removal System
Lightsense Technologies, Ltd.
Not ingested
K202172
StarWalker
Fotona D.O.O.
Not ingested
K191685
PicoWay Laser System
Candela Corporation
K182997
enlighten III Laser System
Cutera, Inc.
K173199
PicoSure Workstation
Cynosure, Inc.
Not ingested
K172077
Cutera enlighten III Laser System
Cutera, Inc.
Not ingested
K170597
PicoWay Laser System
Syneron Candela Corporation
K162454
PicoWay Laser System
Syneron Candela Corporation
K160607
PicoWay Laser System
Syneron Candela Corporation
Not ingested
K160480
PicoSure Workstation
Cynosure, Inc.
Not ingested
K153527
PicoWay Laser System
Syneron Candela Corporation
Not ingested

17 submissions cite Cynosure, LLC as a predicate