Product areas
FDA product code distribution
Cutera, Inc.
Country / region:United States (US)
510(k) submissions
9 total
| 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
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Not ingested - K160968
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Not ingested - K230021
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Not ingested - K232939
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Not ingested - K213461
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Not ingested - K041242
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Not ingested - K170597
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Not ingested - K172077
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Not ingested - K173199
PicoSure Workstation
- K133254
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Not ingested - K170936
Cutera enlighten III Laser System
- K170597
PicoWay Laser System
- K160480
—
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Not ingested - K163222
Discovery Pico Family
- K160488
Cutera enlighten III Laser System
- K133254
—
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Not ingested - K073549
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Not ingested - K073549
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Not ingested - K121346
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Not ingested - K133254
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Not ingested - K133945
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Not ingested - K140727
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Not ingested - K023954
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Not ingested - K120235
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Not ingested - K132185
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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
Not ingested - K240983
Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
- K231054
V-Laser
- K230660
AviClear Laser System
Not ingested - K223540
AvalancheLase Family
- K203788
DermaV Laser System
Not ingested - K191685
PicoWay Laser System
- K183156
V-Laser
Not ingested - K182997
enlighten III Laser System
Not ingested - 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