Product areas
FDA product code distribution
Cynosure, LLC
Country / region:United States (US)
510(k) submissions
7
Filtered: GEX
Latest clearance
2024-03-08
Product codes
1
GEX
510(k) submissions
7 total · filtered by GEX
| 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 |
Company profile
- Canonical name
- Cynosure, LLC
- Aliases
- Cynosure, Inc.
- Country
- United States(US)
Cited predicates
17- K233090
DEKA AGAIN PRO family
- K193426
Elite iQ
- K121346
—
—
Not ingested - K133254
—
—
Not ingested - K173199
PicoSure Workstation
- K120622
—
—
Not ingested - K141425
—
—
Not ingested - K150516
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
- K133254
—
—
Not ingested - K160480
PicoSure Workstation
- K133254
—
—
Not ingested - K143105
Picosure Workstation
- K133254
—
—
Not ingested - K140719
—
—
Not ingested - K141305
—
—
Not ingested - K103014
—
—
Not ingested - K121127
—
—
Not ingested
Cynosure, LLC references 17 predicate/reference devices
Cited as predicate
17- K260307
Diode Laser Therapy Systems (V19)
- K252369
Boston Pico755
- K243957
PICOALEX
- K240396
Elite iQ PRO (M122K1)
- K210226
PicoSure Workstation
- K210168
Diode Laser Therapy Systems
- K202848
S2 Pigment Removal System
- K202172
StarWalker
- K191685
PicoWay Laser System
- K182997
enlighten III Laser System
- K173199
PicoSure Workstation
- K172077
Cutera enlighten III Laser System
- K170597
PicoWay Laser System
- K162454
PicoWay Laser System
- K160607
PicoWay Laser System
- K160480
PicoSure Workstation
- K153527
PicoWay Laser System
17 submissions cite Cynosure, LLC as a predicate