FDA.reportPublic FDA data

truSculpt 3D

Primary DI
00816722022431
Brand
truSculpt 3D
Company
CUTERA, INC.
Model
truSculpt 3D
Device description
truSculpt 3D RF Handpiece
Published
2017-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816722022431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816722022431008167220224318167220224310816722022431

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring systemAn assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 415 657-5500info@cutera.com

Regulatory Flags#

DUNS number
041071643
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816722022158Pearl FractionalPearl Fractional2016-09-23
00816722022714AviClearAviClear Large handpiece2025-08-18
00816722022707AviClearAviClear2022-04-01
00816722021700AviClearAviClear2022-04-01
00816722021007CoolGlide CVCoolGlide CV2016-09-23
00816722021014CoolGlide ExcelCoolGlide Excel2016-09-23
00816722021021CoolGlide VantageCoolGlide Vantage2016-09-23
00816722021038CoolGlide GenesisCoolGlide Genesis2016-09-23
00816722021205Genesis PlusGenesis Plus2016-09-23
00816722021502excel HRexcel HR2016-09-23
00816722023209Genesis Plus 1 mm Spot Size AdapterGenesis Plus 1 mm Spot Size Adapter2016-09-23
00816722021403truSculpttruSculpt2016-09-23
00816722021410truSculpt truSculpt 2 MHz2017-03-21
00816722021427truSculpt iDtruSculpt iD2018-06-27
00816722022400truSculpt 16truSculpt 162016-09-19
00816722022417truSculpt 25truSculpt 252016-09-19
00816722022424truSculpt 40truSculpt 402016-09-19
00816722022806AcutipAcutip2023-05-15
00816722021816xeo+ SAxeo+ SA2022-11-30
00816722022813Limelight Limelight 2022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809932290075NeoSculpt PlusS&M Medical Inc.PBX2026-10-20
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDPBX2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDPBX2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDPBX2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDPBX2026-10-20
06973011720134Diode Laser Therapy SystemSanhe LEFIS Electronics Co., LtdGEX2026-10-16
00840456400814MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456400821MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456401293MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456401309MOSES RaydarLUMENIS LTD.GEX2026-10-13
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDPBX2026-10-12
08809932290082NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290099NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290105NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290112NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290129NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290136NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290143NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
B17731226455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-10-08
00872320007218SveltivaCAO GROUP, INC.PBX2026-10-01
B17700100852TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
B17700100853TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
06970453310015MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310084MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310114MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06971679500105LED Therapy DeviceBeijing Nubway S&T Co., Ltd.GEX2026-09-24
08032625821120GLOBUSDOMINO SRLPBX2026-09-19
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDPBX2026-08-26
06970745912927ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912934ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17