FDA.reportPublic FDA data

Cellfina System Cart

Primary DI
00840763101015
Brand
Cellfina System Cart
Company
Ulthera, Inc.
Model
Rev R
Catalog number
1010103
Published
2019-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUPPowered Surgical Instrument For Improvement In The Appearance Of CelluliteGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161885000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161885000The Cellfina SystemUlthera, Inc.2016-10-05OUP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840763101015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840763101015008407631010158407631010150840763101015

GMDN Terms#

Term, Definition table
TermDefinition
Operating table accessory trolleyA cart typically designed as a framework on wheels with baskets, shelves, hooks and organizers that is used to store the operating table accessories in an orderly and hygienic manner. This trolley (cart) may be brought into the operation room (OR) so that a choice of operating table accessories, or accessories for a specific surgical procedure is made readily available.

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
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
00850036790013AveliRevelle Aesthetics, Inc.OUP2024-02-26
00850036790006AveliRevelle Aesthetics, Inc.OUP2022-02-14
00840763100742Cellfina Motor Module Device and PackageUlthera, Inc.OUP2020-01-24
00840763100414Cellfina System Disposable TrayUlthera, Inc.OUP2019-07-18
00840763100520Cellfina System Disposable TrayUlthera, Inc.OUP2019-07-18
00840763100612Cellfina System Disposable TrayUlthera, Inc.OUP2019-07-18
00840763100766Cellfina System Disposable TrayUlthera, Inc.OUP2019-07-18
00840763100803Cellfina Prep PackUlthera, Inc.OUP2019-07-18
00840763100827Cellfina System Disposable Procedure KitUlthera, Inc.OUP2019-03-18
00840763100537CellfinaUlthera, Inc.OUP2016-12-14
00840763100544Cellfina Motor Module Device and PackageUlthera, Inc.OUP2016-12-14
10840763100107Cellfina System Procedure Kit (Single Package)Ulthera, Inc.OUP2016-12-12
00840763100087Cellfina Prep Pack for EUUlthera, Inc.OUP2016-12-12
00840763100094Cellfina System Disposable TrayUlthera, Inc.OUP2016-09-07
00840763100117Cellfina Motor Module Device and PackageUlthera, Inc.OUP2016-09-07
00840763100124Cellfina Prep PackUlthera, Inc.OUP2016-09-07
00840763100377Cellfina Prep PackUlthera, Inc.OUP2016-09-07
00840763100384Cellfina Motor Module Device and PackageUlthera, Inc.OUP2016-09-07
00840763100391Cellfina System Disposable TrayUlthera, Inc.OUP2016-09-07
00840763100407Cellfina System Disposable TrayUlthera, Inc.OUP2016-09-07
00840763100568Cellfina Motor Module Device and PackageUlthera, Inc.OUP2016-09-07