Morpheus8 Burst Applicator

Basic Information

• Brand Name: Morpheus8 Burst Applicator
• Primary DI: 07290019863120
• Version / Model: AG613055A
• Catalog Number: AG613055A
• Company Name: INMODE M.D LTD
• Labeler DUNS: 600417351
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-21
• Public Version: 4
• Public Version Date: 2026-04-20
• Public Version Status: Update
• Public Device Record Key: 623d149d-1258-4c37-bacb-ea10893ed1cd

Device Description

Morpheus8 Applicator ( BLK)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58455	Radio-frequency skin surface treatment system applicator	A handpiece component of a radio-frequency skin surface treatment system designed to be used by a healthcare professional to deliver bipolar radio-frequency (RF) energy to the skin surface for skin resurfacing. It is typically designed to deliver RF energy to the skin in a non-homogenous fractional manner, via an array of multi-electrode pins, to leave minimal-impact areas of skin to facilitate healing. The applicator connects with the system’s control unit and may include vacuum to facilitate its coupling with the skin. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290019863120	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221571	000
K231790	000
K251254	000
K251632	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 65 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 110 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 110 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius