Product areas
FDA product code distribution
Cutera, Inc.
Country / region:United States (US)
510(k) submissions
9
Filtered: GEX
Latest clearance
2025-07-11
Product codes
1
GEX
510(k) submissions
9 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K251149 | AviClear Laser System | GEX | Class 2 | 2025-07-11 |
| K233237 | xeo+ Family | GEX | Class 2 | 2023-12-15 |
| K230660 | AviClear Laser System | GEX | Class 2 | 2023-06-06 |
| K213461 | AviClear Laser System | GEX | Class 2 | 2022-03-24 |
| K182997 | enlighten III Laser System | GEX | Class 2 | 2018-12-12 |
| K172077 | Cutera enlighten III Laser System | GEX | Class 2 | 2017-10-27 |
| K170936 | Cutera enlighten III Laser System | GEX | Class 2 | 2017-04-25 |
| K160488 | Cutera enlighten III Laser System | GEX | Class 2 | 2016-10-28 |
| K153671 | Family of CoolGlide Aesthetic Lasers | GEX | Class 2 | 2016-03-09 |
Company profile
- Canonical name
- Cutera, Inc.
- Country
- United States(US)
Cited predicates
26- K230660
AviClear Laser System
- K160968
—
—
Not ingested - K230021
IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
- K232939
IPL Hair Removal Device
- K213461
AviClear Laser System
- K041242
—
—
Not ingested - K170597
PicoWay Laser System
- K172077
Cutera enlighten III Laser System
- K173199
PicoSure Workstation
- K133254
—
—
Not ingested - K170936
Cutera enlighten III Laser System
- K170597
PicoWay Laser System
- K160480
PicoSure Workstation
- K163222
Discovery Pico Family
- K160488
Cutera enlighten III Laser System
- K133254
—
—
Not ingested - K073549
—
—
Not ingested - K073549
—
—
Not ingested - K121346
—
—
Not ingested - K133254
—
—
Not ingested - K133945
—
—
Not ingested - K140727
—
—
Not ingested - K023954
—
—
Not ingested - K120235
—
—
Not ingested - K132185
—
—
Not ingested - K143723
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
Cutera, Inc. references 26 predicate/reference devices
Cited as predicate
13- K251149
AviClear Laser System
- K240983
Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
- K231054
V-Laser
- K230660
AviClear Laser System
- K223540
AvalancheLase Family
- K203788
DermaV Laser System
- K191685
PicoWay Laser System
- K183156
V-Laser
- K182997
enlighten III Laser System
- K173700
PICOPLUS Laser System
- K172077
Cutera enlighten III Laser System
- K170936
Cutera enlighten III Laser System
- K170626
Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece
13 submissions cite Cutera, Inc. as a predicate