FDA.reportPublic FDA data

Morpheus8 90 Tip

Primary DI
07290019863212
Brand
Morpheus8 90 Tip
Company
INMODE M.D LTD
Model
AG613135A
Catalog number
AG613135A
Device description
Morpheus8 90 Tip for Morpheus8 90 Applicator
Published
2026-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240017000InMode System with the Morpheus8 90 ApplicatorInMode , Ltd.2024-06-13GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019863212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019863212072900198632127290019863212

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring system applicator tipA removable endpiece that is attached to a radio-frequency (RF) skin contouring system applicator (handpiece), used to regulate the delivery of RF energy to the patient during treatment. As a procedural safety measure, the device may permit the transfer of energy only when a correct surface contact is established. It may also be used to cool the skin and monitor its temperature to protect the epidermis during treatment. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 KiloPascal90 KiloPascal
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
600417351
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019863205Morpheus8 90 ApplicatorAG613133AAG613133A2026-04-19
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
07290019863267Luxora SystemAG613237AAG613238A2025-08-11

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Primary DI, Brand, Company table
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B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
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07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
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B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
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