FDA.reportPublic FDA data

LIPOcel

Primary DI
08800020100009
Brand
LIPOcel
Company
Jeisys Medical Inc.
Model
LIPOcel
Device description
Focused Ultrasound for tissue heat or mechanical cellular disruption
Published
2020-02-25
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
OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular DisruptionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181896000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181896000LIPOcelJeisys Medical, Inc.2019-10-18OHV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800020100009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800020100009088000201000098800020100009

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound hyperthermia system transducer, extracorporealAn ultrasound (US) transducer assembly that is a component of an ultrasound hyperthermia system used to induce systemic or local body heating of sufficient magnitude to create a targeted therapeutic effect. It is mounted within the gantry or housing of the hyperthermia system or mounted on a floor, wall, or ceiling suspension that allows the operator to position the transducer assembly external to the patient during treatment. It is typically composed of a single transducer element or an array of transducer elements, i.e., piezoelectric or active element(s), or crystal(s) and associated damping, backing, and matching layer materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690275362
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800020110688INTRAGen HandpieceINTRAGen Handpiece2026-07-29
08800020100153LIPOcelLIPOcel2026-07-21
08800020100481POTENZA TipCP-21 TIP2026-07-21
08800020101754POTENZA HandpieceAC Handpiece2026-07-21
08800020101761POTENZA HandpieceS Handpiece2026-07-21
08800020101778POTENZA HandpieceMotor Handpiece2026-07-21
08800020101891FootswitchLIPOcel_Foot Switch2026-07-21
08800020109088LIPOcel CartridgeL13 Cartridge2026-07-21
08800020109439TRI-BEAM ARMTRI-BEAM Articulated Arm 022026-07-21
08800020110541INTRAcel PremiumINTRAcel Premium Fractional RF Micro Needle (FRM) 2026-07-21
08800020111845P-NAIN SYSTEMP-NAIN SYSTEM2026-07-21
08800020111852HILTHERAHILTHERA 4.02026-07-21
08800020101211INTRAgen TipKT-152022-03-29
08800020105028INTRAgen TipKT-072016-10-31
08800020100276INTRAcel TipINTRAcel Tip 10102026-07-16
08800020100283INTRAcel TipINTRAcel Tip 32026-07-16
08800020100306INTRAcel TipINTRAcel Tip 10122026-07-16
08800020100313INTRAcel TipINTRAcel Tip 10132026-07-16
08800020100320INTRAcel TipINTRAcel Tip 20112026-07-16
08800020100337INTRAcel TipN16 Tip2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800020100153LIPOcelJeisys Medical Inc.OHV2026-07-21
08800020101891FootswitchJeisys Medical Inc.OHV2026-07-21
08800020109088LIPOcel CartridgeJeisys Medical Inc.OHV2026-07-21
07290018152089Sofwave ApplicatorSOFWAVE MEDICAL LTDOHV2025-02-16
00840763101145Ulthera System Control Unit PRIMEUlthera, Inc.OHV2024-04-10
00840763101152Ulthera System HandpieceUlthera, Inc.OHV2024-04-08
07290018152058Sofwave ApplicatorSOFWAVE MEDICAL LTDOHV2023-04-24
07290018152065Sofwave ApplicatorSOFWAVE MEDICAL LTDOHV2023-04-24
07290018152027Sofwave ApplicatorSOFWAVE MEDICAL LTDOHV2021-05-27
07290018152003SofwaveSOFWAVE MEDICAL LTDOHV2019-11-10
07290018152010Sofwave ApplicatorSOFWAVE MEDICAL LTDOHV2019-11-10
00840763100025Ulthera System Transducer DS 7-3.0 Ulthera, Inc.OHV2019-07-18
00840763100834Ulthera System TransducerUlthera, Inc.OHV2018-04-27
00840763100841Ulthera System TransducerUlthera, Inc.OHV2018-04-27
00840763100858Ulthera System TransducerUlthera, Inc.OHV2018-04-27
00840763100865Ulthera System TransducerUlthera, Inc.OHV2018-04-27
00840763100889Ulthera System TransducerUlthera, Inc.OHV2018-04-27
00840763100896Ulthera System TransducerUlthera, Inc.OHV2018-04-27
00840763100902Ulthera System Control UnitUlthera, Inc.OHV2018-04-27
00840763100919Ulthera System HandpieceUlthera, Inc.OHV2018-04-27
07290109952741UltraShape Power System, PackagedSYNERON MEDICAL LTDOHV2018-03-26
00816995027027VASERSOLTA MEDICALOHV2017-12-14
00840763100018Ulthera System HandpieceUlthera, Inc.OHV2017-05-23
00840763100261Ulthera System HandpieceUlthera, Inc.OHV2017-05-23
00840763100476Ulthera SystemUlthera, Inc.OHV2017-05-23
00840763100483Ulthera System HandpieceUlthera, Inc.OHV2017-05-23
07290109952451UltraShape System, Packaged for USSYNERON MEDICAL LTDOHV2017-01-17
00840763100032Ulthera System TransducerUlthera, Inc.OHV2016-12-14
00840763100049Ulthera System TransducerUlthera, Inc.OHV2016-12-14
00840763100056Ulthera System TransducerUlthera, Inc.OHV2016-12-14