FDA.reportPublic FDA data

EmFace or Evoke

Primary DI
07290016633504
Brand
EmFace or Evoke
Company
INMODE M.D LTD
Model
AG608082A
Catalog number
AG608082A
Device description
The EmFace Device with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
Published
2022-10-27
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
07290016633504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016633504072900166335047290016633504

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 Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius65 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
06974223650141WinForthShenzhen Leaflife Technology Co., Ltd.PBX2026-04-22
07290016746402V-FR HandpieceVIORA LTDPBX2026-04-19
07290016746501V-FR TipVIORA LTDPBX2026-04-19
00810060832851Venus NovaVenus Concept Inc.PBX2026-04-15
00850055552494BellaTform ApplicatorInbella Medical IncPBX2026-04-02
00850055552180BellaPlus90 ApplicatorInbella Medical IncPBX2026-03-30
00850055552715i-BellaForma ApplicatorInbella Medical IncPBX2026-03-30
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
08056182720634SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
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
07290016814569PRO MAX, System, 110VENDYMED MEDICAL LTDPBX2025-11-17
08034108513270ONDA PRODEKA M.E.L.A. SRLPBX2025-11-17
08034108513263body ESTIQDEKA M.E.L.A. SRLPBX2025-09-26
07290016746785V-FC Pro FullVIORA LTDPBX2025-09-01
07290016746808V-FC Pro TipVIORA LTDPBX2025-09-01