FDA.reportPublic FDA data

Ulthera System Cart

Primary DI
00840763101169
Brand
Ulthera System Cart
Company
Ulthera, Inc.
Model
UR-1 Rev. A
Published
2024-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FWYTable, Operating-Room, Non-Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWYTable, Operating-Room, Non-ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840763101169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840763101169008407631011698407631011690840763101169

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010981554
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
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
00840763100216Ulthera System Control UnitUC-1 Rev. H2016-09-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04057027972793UFSK-OSYS Treatment tableUFSK-International OSYS GmbHFWY2026-03-02
B510OT30K0ADVANCED TABLE, OPERATING-ROOM, NON-ELECTRICALADVANCED INSTRUMENTATIONS, INC.FWY2020-05-27