FDA.reportPublic FDA data

Face Applicator (Cheek Left )

Primary DI
17290016633549
Brand
Face Applicator (Cheek Left )
Company
INMODE M.D LTD
Model
AG609293A
Catalog number
AG609293A
Device description
Cheek Left Applicator
Published
2022-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191855000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191855000EmFace DeviceInmode MD , Ltd.2019-10-29PBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016633549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729001663354917290016633549

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin surface treatment/fat liquefaction system control unitA mains electricity (AC-powered) device designed to supply radio-frequency (RF) energy to dedicated applicators (handpieces) for skin surface treatment and fat liquefaction procedures. It typically includes an RF generator, user interface/controls, and inputs for other system components. It typically provides continuous tissue temperature monitoring, and impedance and power monitoring with tissue overheating safety systems.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure90 KiloPascal110 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal110 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-887-367-4556contact@inmode.com

Regulatory Flags#

DUNS number
600417351
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019863205Morpheus8 90 ApplicatorAG613133AAG613133A2026-04-19
07290019863212Morpheus8 90 TipAG613135AAG613135A2026-04-19
07290019863410InModeRF hand pieceHP1722B6AHP1722B6A2026-04-16
07290019863274InMode RF hand pieceHP060999AHP060999A2025-02-20
07290019863281InMode RF hand pieceHP101396AHP101396A2025-02-20
07290019863298InMode RF hand pieceHP172296AHP172296A2025-02-20
07290019863083Morpheus8 Resurfacing TIPAG613051AAG613051A2024-08-22
07290019863090Morpheus8 Prime 12 pin TIPAG613052AAG613052A2024-08-22
07290019863106Morpheus8 40 pin TIPAG613053AAG613053A2024-08-22
07290019863113Morpheus8 24 pin TIPAG613054AAG613054A2024-08-22
07290019863120Morpheus8 Burst ApplicatorAG613055AAG613055A2024-08-21
07290019863137Morpheus8 Burst Deep ApplicatorAG613056AAG613056A2024-08-21
07290019863076InModeRF hand pieceHP2539B6AHP2539B6A2024-08-08
07290019863045InMode RF hand pieceHP102206AHP102206A2024-04-25
07290019863052InMode RF hand pieceHP253966AHP253966A2024-04-25
07290019863069InModeRF hand pieceHP1022B6AHP1022B6A2024-08-08
07290019863250Ignite RF SystemAG613237AAG613237A2024-03-24
07290016633689Transform (T3 Applicator) AG609899A AG609899A 2022-10-27
07290016633498Evolve SystemAG608081AAG608081A2022-10-26
07290016633252InModeAG606666AAG606666A2017-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850055552005BellaBodyFX ApplicatorInbella Medical IncPBX2026-03-26
00850055552036BellaForma ApplicatorInbella Medical IncPBX2026-03-26
00850055552043BellaPlus ApplicatorInbella Medical IncPBX2026-03-26
00850055552067BellaMiniFX ApplicatorInbella Medical IncPBX2026-03-26
00850055552470InBellaBody SystemInbella Medical IncPBX2026-03-25
00850055552555InBellaMax SystemInbella Medical IncPBX2026-03-25
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08056182721143SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721167SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721174SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721181SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721198SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721204SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721211SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721327SUPERCHARGE HYDRA FASCIA ELECTRODES UNIBELL SRLPBX2026-03-16
08800092098013D20-RF0BDaeyang Medical Co., Ltd.PBX2026-03-10
04053915986880Tecarpuls IIZimmer MedizinSysteme GmbHPBX2026-02-12
07290016746563V-IPL Optic set Full 6 filtersVIORA LTDPBX2025-12-22
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08034108513270ONDA PRODEKA M.E.L.A. SRLPBX2025-11-17
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