EmPowerRF platform

Primary DI
07290016633702
Brand
EmPowerRF platform
Company
INMODE M.D LTD
Model
AG609933A
Catalog number
AG609933A
Device description
InMode RF Pro system with the non-invasive applicators employs RF energy for various applications:• i-Forma, Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm,and temporary improvement of local blood circulation.• WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinklesand rhytids.• BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporaryimprovement of local blood circulation and temporary reduction in the appearance of cellulite.The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications:• Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacingof the skin.• Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures forelectrocoagulation and hemostasis.At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV• Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis.At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV
Published
2022-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
ISAMassager, Therapeutic, Electric
NUVMassager, Vacuum, Light Induced Heating
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
ISAMassager, Therapeutic, ElectricPhysical Medicine1
NUVMassager, Vacuum, Light Induced HeatingGeneral, Plastic Surgery2
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201150000
K210492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201150000InMode RF Multi-SystemInMode , Ltd.2020-07-22GEI
K210492000InMode RF Pro SystemInmode MD , Ltd.2021-07-12GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016633702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016633702072900166337027290016633702

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

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 Celsius35 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

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