Syneron-Candela

Country / region:United States (US)

510(k) submissions

Latest clearance

2018-07-11

Product codes

GEX

Cited as predicate

View list →

Product areas

FDA product code distribution

GEX6

510(k) submissions

6 total

K number	Device name	Product code	Class	Decision date
K181523	Syneron CO2RE System	GEX	Class 2	2018-07-11
K180593	Vbeam Prima Laser System	GEX	Class 2	2018-06-05
K170597	PicoWay Laser System	GEX	Class 2	2017-05-25
K162454	PicoWay Laser System	GEX	Class 2	2017-02-01
K160607	PicoWay Laser System	GEX	Class 2	2016-07-05
K153527	PicoWay Laser System	GEX	Class 2	2016-03-02

Company profile

Canonical name: Syneron-Candela
Aliases: Syneron-Candela Corp, Syneron Candela Corporation
Country: United States(US)

Cited predicates

K151655
—
—
Not ingested
K050779
—
—
Not ingested
K050673
—
—
Not ingested
K150326
PicoWay Laser System
Candela Corporation
K162454
PicoWay Laser System
Syneron Candela Corporation
K160607
PicoWay Laser System
Syneron Candela Corporation
K153527
PicoWay Laser System
Syneron Candela Corporation
K143105
Picosure Workstation
Cynosure, Inc.
K142372
—
—
Not ingested
K140719
—
—
Not ingested
K140122
—
—
Not ingested
K133364
—
—
Not ingested
K133283
—
—
Not ingested
K121346
—
—
Not ingested
K120510
—
—
Not ingested
K112715
—
—
Not ingested
K033461
—
—
Not ingested
K160607
PicoWay Laser System
Syneron Candela Corporation
K033461
—
—
Not ingested
K112715
—
—
Not ingested
K120510
—
—
Not ingested
K121346
—
—
Not ingested
K133283
—
—
Not ingested
K133364
—
—
Not ingested
K140719
—
—
Not ingested
K142372
—
—
Not ingested
K143105
Picosure Workstation
Cynosure, Inc.
K150326
PicoWay Laser System
Candela Corporation
K153527
PicoWay Laser System
Syneron Candela Corporation
K140122
—
—
Not ingested
K112715
—
—
Not ingested
K120510
—
—
Not ingested
K121346
—
—
Not ingested
K133283
—
—
Not ingested
K133364
—
—
Not ingested
K140122
—
—
Not ingested
K140719
—
—
Not ingested
K142372
—
—
Not ingested
K143105
—
—
Not ingested
K150326
—
—
Not ingested
K153527
PicoWay Laser System
Syneron Candela Corporation
K033461
—
—
Not ingested
K150326
—
—
Not ingested
K143105
—
—
Not ingested
K142372
—
—
Not ingested
K140727
—
—
Not ingested
K140719
—
—
Not ingested
K140122
—
—
Not ingested
K133364
—
—
Not ingested
K133283
—
—
Not ingested
K121346
—
—
Not ingested
K120510
—
—
Not ingested
K112715
—
—
Not ingested

Syneron-Candela references 53 predicate/reference devices

Cited as predicate

K233757
TitanPico Laser Workstation (PICO-450)
Rhein Laser Technologies Co., Ltd.
Not ingested
K212663
HELIOS IV 785
Laseroptek Co., Ltd.
K210847
UltraClear Fractional Laser System
Fa International, LP
Not ingested
K203491
PicoLO Nd: YAG Picosecond Laser System
Laseroptek Co., Ltd.
K192583
PicoLazer Laser System
Rohrer Aesthetics, LLC
Not ingested
K191685
PicoWay Laser System
Candela Corporation
K191685
PicoWay Laser System
Candela Corporation
K191685
PicoWay Laser System
Candela Corporation
K191685
PicoWay Laser System
Candela Corporation
K183452
Vbeam Prima Laser System
Candela Corp.
Not ingested
K183392
PicoLO Nd:YAG Picosecond Laser System
Laseroptek Co., Ltd.
K182997
enlighten III Laser System
Cutera, Inc.
Not ingested
K181272
Picocare Family
Wontech Co., Ltd.
Not ingested
K172376
Discovery Pico, Discovery Pico Plus
Quanta System Spa
K172077
Cutera enlighten III Laser System
Cutera, Inc.
K171945
Discovery Pico, Discovery Pico Plus
Quanta System Spa
K170597
PicoWay Laser System
Syneron Candela Corporation
K170597
PicoWay Laser System
Syneron Candela Corporation
K170597
PicoWay Laser System
Syneron Candela Corporation
K162454
PicoWay Laser System
Syneron Candela Corporation
K162454
PicoWay Laser System
Syneron Candela Corporation
K160607
PicoWay Laser System
Syneron Candela Corporation

22 submissions cite Syneron-Candela as a predicate