Company ยท US
Cutera, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2025. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 20 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 2 |
| NUV | Massager, Vacuum, Light Induced Heating | 2 |
| OPT | Infrared Hematoma Detector | 1 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 11, 2025 | K251149 | AviClear Laser System Cutera, Inc. | GEX |
| Dec 15, 2023 | K233237 | xeo+ Family Cutera, Inc. | GEX |
| Jun 6, 2023 | K230660 | AviClear Laser System Cutera, Inc. | GEX |
| Nov 3, 2022 | K223110 | truSculpt iD Cutera, Inc. | GEI |
| Jul 13, 2022 | K221407 | truSculpt iD Cutera, Inc. | GEI |
| Mar 24, 2022 | K213461 | AviClear Laser System Cutera, Inc. | GEX |
| Dec 12, 2018 | K182997 | enlighten III Laser System Cutera, Inc. | GEX |
| Jun 6, 2018 | K180709 | truSculpt RF Device; truSculpt; truSculpt 3D Cutera, Inc. | PBX |
| Oct 27, 2017 | K172077 | Cutera enlighten III Laser System Cutera, Inc. | GEX |
| Aug 2, 2017 | K172004 | truSculpt Cutera, Inc. | PBX |
| Apr 25, 2017 | K170936 | Cutera enlighten III Laser System Cutera, Inc. | GEX |
| Dec 9, 2016 | K162512 | truSculpt Cutera, Inc. | PBX |
| Oct 28, 2016 | K160488 | Cutera enlighten III Laser System Cutera, Inc. | GEX |
| Mar 9, 2016 | K153671 | Family of CoolGlide Aesthetic Lasers Cutera, Inc. | GEX |
| Nov 6, 2014 | K140727 | CUTERA PICOSECOND LASER SYSTEM Cutera, Inc. | GEX |
| Sep 5, 2014 | K133739 | TRUSCULPT Cutera, Inc. | PBX |
| Aug 11, 2014 | K133945 | CUTERA PICOSECOND LASER SYSTEM Cutera, Inc. | GEX |
| Dec 6, 2013 | K132185 | FAMILY OF COOLGLIDE AESTHETIC LASERS Cutera, Inc. | GEX |
| May 15, 2013 | K122493 | GENESISPLUS Cutera, Inc. | GEX |
| Nov 2, 2012 | K122389 | TRUSCULPT Cutera, Inc. | PBX |
| Jun 22, 2011 | K102954 | CUTERA QSWITCH LASER SYSTEM Cutera, Inc. | GEX |
| Apr 5, 2011 | K103626 | CUTERA GENESISPLUS LASER SYSTEM Cutera, Inc. | PDZ |
| Oct 1, 2009 | K092195 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) Cutera, Inc. | NUV |
| Aug 15, 2008 | K080530 | MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE Cutera, Inc. | GEX |
| Apr 8, 2008 | K080300 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) Cutera, Inc. | NUV |
| Mar 27, 2007 | K070138 | CUTERA ER:YAG LASER HANDPIECE Cutera, Inc. | GEX |
| Mar 27, 2007 | K063867 | CUTERA ER:YSGG LASER HANDPIECE Cutera, Inc. | GEX |
| Mar 31, 2005 | K050679 | CUTERA SOLERA OPUS AESTHETIC PRODUCT Cutera, Inc. | GEX |
| Mar 31, 2005 | K050047 | CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY Cutera, Inc. | GEX |
| Jan 31, 2005 | K050069 | CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT Cutera, Inc. | GEX |
| Oct 18, 2004 | K042165 | CUTERA TABLETOP AESTHETIC PRODUCT Cutera, Inc. | ILY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2013 | Cutera, Inc. Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA
The truSculpt massage device i Terminated |
OPT | K122389 |
| Nov 9, 2010 | Cutera Inc Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA
Infrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical he Terminated |
ILY | K042165 |