cutera.comxeo+ Family
Cutera, Inc.
CUTERA, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2954354 | 3002900199 | CUTERA, INC. | 1 | Y | 2026-01-01 | 3240 BAYSHORE BLVD BRISBANE CA US 94005 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00816722021007 | CoolGlide CV - CoolGlide CV Laser System | 1 415 657-5500 | info@cutera.com |
| 00816722021014 | CoolGlide Excel - CoolGlide Excel Laser System | 1 415 657-5500 | info@cutera.com |
| 00816722021021 | CoolGlide Vantage - CoolGlide Vantage Laser System | 1 415 657-5500 | info@cutera.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 56563 | 1111366887 | K990903 | LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) | GEX | 1999-08-27 |
| 56563 | 1590873324 | K951034 | AURA LASER SYSTEM | GEX | 1995-04-13 |
| 56563 | 1677824830 | K251149 | AviClear Laser System | GEX | 2025-07-11 |
| 56563 | 1600188161 | K233237 | xeo+ Family | GEX | 2023-12-15 |
| 56563 | 1285305620 | K221407 | truSculpt iD | GEI | 2022-07-13 |
| 56563 | 2043108745 | K213461 | AviClear Laser System | GEX | 2022-03-24 |
| 56563 | 1526406380 | K192039 | Torc Body | NGX | 2020-03-29 |
| 56563 | 1889343827 | K182997 | enlighten III Laser System | GEX | 2018-12-12 |
| 56563 | 1991834255 | K180709 | truSculpt RF Device; truSculpt; truSculpt 3D | PBX | 2018-06-06 |
| 56563 | 1211228900 | K172077 | Cutera enlighten III Laser System | GEX | 2017-10-27 |
| 56563 | 1339313888 | K153671 | Family of CoolGlide Aesthetic Lasers | GEX | 2016-03-09 |
| 56563 | 1107254551 | K132185 | FAMILY OF COOLGLIDE AESTHETIC LASERS | GEX | 2013-12-06 |
| 56563 | 1953206231 | K122493 | GENESISPLUS | GEX | 2013-05-15 |
| 56563 | 1291938378 | K080530 | MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE | GEX | 2008-08-15 |
| 56563 | 1129171675 | K063867 | CUTERA ER:YSGG LASER HANDPIECE | GEX | 2007-03-27 |
| 56563 | 1797612655 | K050679 | CUTERA SOLERA OPUS AESTHETIC PRODUCT | GEX | 2005-03-31 |
| 56563 | 1698738314 | K050047 | CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY | GEX | 2005-03-31 |
| 56563 | 1495520669 | K042165 | CUTERA TABLETOP AESTHETIC PRODUCT | ILY | 2004-10-18 |
| 56563 | 1104165935 | K041930 | VARILITE LASER SYSTEM | GEX | 2004-09-10 |
| 56563 | 1197809908 | K034011 | GEMINI SURGICAL LASER SYSTEM & ACCESSORIES | GEX | 2004-03-30 |
| 56563 | 1311356975 | K033768 | ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE | ILY | 2004-02-17 |
| 56563 | 1253251571 | K023954 | ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES | GEX | 2003-03-18 |
| 56563 | 1091045745 | K022226 | ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS | GEX | 2002-10-08 |
| 56563 | 1357625256 | K014040 | FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS | GEX | 2002-06-03 |
| 56563 | 1788460507 | K003765 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | GEX | 2001-03-06 |
| 56563 | 1013946214 |
Product Codes Associated With Registrations#
PMN#
AviClear Laser System
Cutera, Inc.
AviClear Laser System
Cutera, Inc.
Enlighten III Laser System
Cutera, Inc.
TruSculpt RF Device; TruSculpt; TruSculpt 3D
Cutera, Inc.
Cutera Enlighten III Laser System
Cutera, Inc.
TruSculpt
Cutera, Inc.
Cutera Enlighten III Laser System
Cutera, Inc.
TruSculpt
CUTERA, INC.
Cutera Enlighten III Laser System
Cutera, Inc.
Family Of CoolGlide Aesthetic Lasers
CUTERA, INC.
CUTERA PICOSECOND LASER SYSTEM
CUTERA, INC.
TRUSCULPT
CUTERA, INC.
CUTERA PICOSECOND LASER SYSTEM
CUTERA, INC.
FAMILY OF COOLGLIDE AESTHETIC LASERS
CUTERA, INC.
GENESISPLUS
CUTERA, INC.
TRUSCULPT
CUTERA, INC.
CUTERA QSWITCH LASER SYSTEM
CUTERA, INC.
CUTERA GENESISPLUS LASER SYSTEM
CUTERA, INC.
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
CUTERA, INC.
MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
CUTERA, INC.
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
CUTERA, INC.
CUTERA ER:YAG LASER HANDPIECE
Cutera, Inc.
CUTERA ER:YSGG LASER HANDPIECE
CUTERA, INC.
CUTERA SOLERA OPUS AESTHETIC PRODUCT
CUTERA, INC.
CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY
CUTERA, INC.
CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT
CUTERA, INC.
CUTERA TABLETOP AESTHETIC PRODUCT
CUTERA, INC.
GUDID#
Pearl Fractional - Pearl Fractional Laser Handpiece
2016-09-23
AviClear - Large handpiece for AviClear laser sytsem
2025-08-18
AviClear - Universal handpiece for AviClear laser sytsem
2022-04-01
AviClear - AviClear Laser System
2022-04-01
CoolGlide CV - CoolGlide CV Laser System
2016-09-23
CoolGlide Excel - CoolGlide Excel Laser System
2016-09-23
CoolGlide Vantage - CoolGlide Vantage Laser System
2016-09-23
CoolGlide Genesis - CoolGlide Genesis Laser System
2016-09-23
Genesis Plus - Genesis Plus Laser System
2016-09-23
excel HR - excel HR Laser System
2016-09-23
Genesis Plus 1 mm Spot Size Adapter
2016-09-23
truSculpt - truSculpt RF Device
2016-09-23
truSculpt - truSculpt 3D RF Device
2017-03-21
truSculpt iD - truSculpt iD RF Device (Rebranded as truSculpt RF Device in June 2023)
2018-06-27
truSculpt 16 - truSculpt 16 RF Handpiece
2016-09-19
truSculpt 25 - truSculpt 25 RF Handpiece
2016-09-19
truSculpt 40 - truSculpt 40 RF Handpiece
2016-09-19
truSculpt 3D - truSculpt 3D RF Handpiece
2017-03-27
Acutip - Acutip IPL Handpiece for xeo+/xeo+ SA
2023-05-15
xeo+ SA - xeo+ SA IPL System
2022-11-30
Limelight - Limelight IPL Handpiece for xeo+/xeo+ SA
2022-11-30
Prowave - Prowave IPL Handpiece for xeo+/xeo+ SA
2022-11-30
enlighten - enlighten SR Laser System
2018-03-02
enlighten - enlighten III Laser System
2016-12-08
xeo+ - xeo+ Laser System
2022-11-30
xeo - xeo Laser System
2016-09-23
xeo SA - xeo SA IPL System
2016-09-23
Solera Opus - Solera Opus IPL System
2016-09-23
Solera Titan - Solera Titan IPL System
2016-09-23
Titan - Titan IPL Handpiece for xeo+/xeo+ SA
2022-11-30
Pearl Fractional - Pearl Fractional Laser Handpiece for xeo+/xeo+ SA
2022-11-30
AcuTip 500 - AcuTip 500 IPL Handpiece
2016-09-23
LimeLight - LimeLight IPL Handpiece
2016-09-23
ProWave LX - ProWave LX IPL Handpiece
2016-09-23
Titan XL - Titan XL IPL Handpiece
2016-09-19
truSculpt 2 RF handpiece - truSculpt 2 cm^2 handheld handpiece for use with truSculpt iD RF device
2022-11-14
truSculpt 5 RF handpiece - truSculpt 4.5 cm^2 handheld handpiece for use with truSculpt iD RF device
2022-11-14
CoolView - CoolView Laser Handpiece for EV+ (EV3)
2020-02-04
Dermastat - Dermastat 2mm Handpiece for EV+
2019-07-15
excel V+ - excel V+ Laser System
2019-07-15