Cutera, Inc.
Medical device manufacturer in Brisbane, CA.
31510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251149 | AviClear Laser SystemGEX · Traditional | 07/11/2025SE |
| K233237 | xeo+ FamilyGEX · Traditional | 12/15/2023SE |
| K230660 | AviClear Laser SystemGEX · Traditional | 06/06/2023SE |
| K223110 | truSculpt iDGEI · Special | 11/03/2022SE |
| K221407 | truSculpt iDGEI · Traditional | 07/13/2022SE |
| K213461 | AviClear Laser SystemGEX · Traditional | 03/24/2022SE |
| K182997 | enlighten III Laser SystemGEX · Traditional | 12/12/2018SE |
| K180709 | truSculpt RF Device; truSculpt; truSculpt 3DPBX · Traditional | 06/06/2018SE |
| K172077 | Cutera enlighten III Laser SystemGEX · Traditional | 10/27/2017SE |
| K172004 | truSculptPBX · Special | 08/02/2017SE |
| K170936 | Cutera enlighten III Laser SystemGEX · Special | 04/25/2017SE |
| K162512 | truSculptPBX · Traditional | 12/09/2016SE |
| K160488 | Cutera enlighten III Laser SystemGEX · Traditional | 10/28/2016SE |
| K153671 | Family of CoolGlide Aesthetic LasersGEX · Traditional | 03/09/2016SE |
| K140727 | Cutera Picosecond Laser SystemGEX · Traditional | 11/06/2014SE |
| K133739 | TrusculptPBX · Traditional | 09/05/2014SE |
| K133945 | Cutera Picosecond Laser SystemGEX · Traditional | 08/11/2014SE |
| K132185 | Family of Coolglide Aesthetic LasersGEX · Traditional | 12/06/2013SE |
| K122493 | GenesisplusGEX · Traditional | 05/15/2013SE |
| K122389 | TrusculptPBX · Special | 11/02/2012SE |
| K102954 | Cutera Qswitch Laser SystemGEX · Traditional | 06/22/2011SE |
| K103626 | Cutera Genesisplus Laser SystemPDZ · Traditional | 04/05/2011SE |
| K092195 | Cutera Multimodal Cellulite Product (Cmmcd)NUV · Special | 10/01/2009SE |
| K080530 | Modification to Cutera Er:Ysgg Laser HandpieceGEX · Special | 08/15/2008SE |
| K080300 | Cutera Multimodal Cellulite Product (Cmmcd)NUV · Traditional | 04/08/2008SE |
| K070138 | Cutera Er:Yag Laser HandpieceGEX · Traditional | 03/27/2007SE |
| K063867 | Cutera Er:Ysgg Laser HandpieceGEX · Traditional | 03/27/2007SE |
| K050679 | Cutera Solera Opus Aesthetic ProductGEX · Traditional | 03/31/2005SE |
| K050047 | Cutera Optional Pulsed Light Hand Piece FamilyGEX · Traditional | 03/31/2005SE |
| K050069 | Cutera Flashlamp Tabletop Aesthetic ProductGEX · Traditional | 01/31/2005SE |
| K042165 | Cutera Tabletop Aesthetic ProductILY · Traditional | 10/18/2004SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0427-2014 Class II | Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency…Cutera received two adverse events associated with the edge of the electrode, when it was pressed against… | 10/16/2013Terminated |
| Z-0329-2011 | Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc…Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy… | 05/08/2010Terminated |