FDA.reportPublic FDA data

Envision System

Primary DI
07290016633726
Brand
Envision System
Company
INMODE M.D LTD
Model
AG609993A
Catalog number
AG609993A
Device description
The Envision Platform with Forma-I, Forma, Morpheus8 and Lumecca Applicators employs two different technologies for various aesthetic applications – Intense Pulsed Light (IPL), and Radiofrequency (RF). The System operates while in contact with any of the following Handpieces: Forma-I and Forma Handpieces employs bi-polar Radiofrequency (RF) technology for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation; Lumecca IPL for treatment of superficial vascular and pigmented lesions; and Morpheus8 for electro-coagulation. The device provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for each patient and applications.
Published
2024-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
GEXPowered Laser Surgical Instrument
ISAMassager, Therapeutic, Electric
NUVMassager, Vacuum, Light Induced Heating
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ISAMassager, Therapeutic, ElectricPhysical Medicine1
NUVMassager, Vacuum, Light Induced HeatingGeneral, Plastic Surgery2
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200293000
K210492000
K221571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200293000InMode System with vTone ApplicatorInMode , Ltd.2020-05-05KPI
K210492000InMode RF Pro SystemInmode MD , Ltd.2021-07-12GEI
K221571000InMode Multi-systemInMode , Ltd.2022-06-30GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016633726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016633726072900166337267290016633726

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] 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 energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

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

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
07290019863359ApexRF ApplicatorAG614409AAG614409A2025-06-04
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

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