Plus AS601654A

GUDID 07290016633245

Firm

INMODE M.D LTD

Radio-frequency skin surface treatment system

• Primary Device ID: 07290016633245
• NIH Device Record Key: 9680a3d1-50f9-441a-bc2c-bf9ca8cc634e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plus
• Version Model Number: AG605904A
• Catalog Number: AS601654A
• Company DUNS: 600417351
• Company Name: INMODE M.D LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-887-367-4556
• Email: contact@inmode.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016633245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153568

FDA Product Code

• ISA: Massager, Therapeutic, Electric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-25

Devices Manufactured by INMODE M.D LTD

• 07290019863267 - Luxora System: 2025-08-19 The Luxora™ device is based on the InMode RF Pro™ platform. The Luxora system employs radiofrequency (RF) energy for use in
• 07290016633313 - Plus Applicator: 2025-08-04 Plus (Plus Plus)
• 07290019863359 - ApexRF Applicator: 2025-06-12 ApexRF handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and te
• 07290019863274 - InMode RF hand piece: 2025-02-28 AccuTite HP 2 Pack black
• 07290019863281 - InMode RF hand piece: 2025-02-28 FaceTite 2-Pack black
• 07290019863298 - InMode RF hand piece: 2025-02-28 InModeRF HP 17x22x46 black
• 07290019863342 - APEX RF System: 2025-01-17 Apex RF system employs radiofrequency (RF) energy for use in dermatological procedures.
• 07290016633573 - Define System: 2025-01-15 The DEFINE System is designed to deliver non-thermal RF energy to the skin and subdermal fat. .