FDA.reportPublic FDA data

truSculpt 2 RF handpiece

Primary DI
00816722022479
Brand
truSculpt 2 RF handpiece
Company
CUTERA, INC.
Model
truSculpt 2 RF handpiece
Device description
truSculpt 2 cm^2 handheld handpiece for use with truSculpt iD RF device
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816722022479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816722022479008167220224798167220224790816722022479

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring system applicator, monopolarA monopolar handpiece that is part of a skin contouring system that uses radio-frequency (RF) energy to provide a capacitively coupled electrical connection for the transfer of radiated energy through a patient's skin in deep heat-mediated skin modification. The current passes from this device to an indifferent return electrode placed on the patient. This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.

Sterilization Methods#

Method table
Method

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
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
00816722022431truSculpt 3DtruSculpt 3D2017-03-27
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
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14