FDA.reportPublic FDA data

Ulthera System Control Unit

Primary DI
00840763100216
Brand
Ulthera System Control Unit
Company
Ulthera, Inc.
Model
UC-1 Rev. H
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular DisruptionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K134032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K134032000ULTHERA SYSTEMUlthera, Inc.2014-06-20OHV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840763100216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840763100216008407631002168407631002160840763100216

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic body contouring systemAn assembly of devices intended for the transdermal application of ultrasonic energy to rupture targeted fat cells in areas where they tend to enlarge (e.g., hips, thighs, abdomen, buttocks), to reshape those areas for cosmetic purposes. The assembly typically consists of a mains electricity (AC-powered) ultrasonic energy generator with user controls/interface and an ultrasonic transducer used to transmit the energy to a target area to emulsify fat cells; it may include a video imaging system that takes into account real-time body movement to precisely position the transducer during treatment. The use of this system may serve as a noninvasive outpatient procedure alternative to liposuction.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010981554
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840763100001Ulthera System Control UnitUC-1 Rev. A2016-09-07
00840763100018Ulthera System HandpieceUH-2 Rev. A2017-05-23
00840763100155Ulthera System Control UnitUC-1 Rev. B2016-09-07
00840763100162Ulthera System Control UnitUC-1 Rev. C2016-09-07
00840763100179Ulthera System Control UnitUC-1 Rev. D2016-09-07
00840763100186Ulthera System Control UnitUC-1 Rev. E2016-09-07
00840763100193Ulthera System Control UnitUC-1 Rev. F2016-09-07
00840763100209Ulthera System Control UnitUC-1 Rev. G2016-09-07
00840763100223Ulthera System Control UnitUC-1 Rev. I2016-09-07
00840763100230Ulthera System Control UnitUC-1 Rev. J2016-09-07
00840763100247Ulthera System Control UnitUC-1 Rev. K2016-09-07
00840763100254Ulthera System Control UnitUC-1 Rev. L2016-09-07
00840763100261Ulthera System HandpieceUH-2 Rev. B2017-05-23
00840763100278Ulthera System HandpieceUH-2 Rev. C2016-09-06
00840763100285Ulthera System HandpieceUH-2 Rev. D2016-09-06
00840763100292Ulthera System HandpieceUH-2 Rev. E2016-09-06
00840763100308Ulthera System HandpieceUH-2 Rev. F2016-12-14
00840763100421Ulthera System HandpieceUH-2 Rev. G2016-12-14
00840763100438Ulthera System HandpieceUH-2 Rev. H2016-12-14
00840763100476Ulthera SystemUC-1 Rev 12017-05-23

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