EmPowerRF platform AG609933A

GUDID 07290016633702

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 wrinkles and rhytids. • BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement 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 resurfacing of the skin. • Fractora Applicator with 24 pins tip is intended for use in 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 • 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

INMODE M.D LTD

Multi-modality skin surface treatment system

• Primary Device ID: 07290016633702
• NIH Device Record Key: 236c4694-d803-4ed7-9b23-b3353e0040f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmPowerRF platform
• Version Model Number: AG609933A
• Catalog Number: AG609933A
• 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
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com
• Phone: 1-887-367-4556
• Email: contact@inmode.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 90 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016633702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210492

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-02
• Device Publish Date: 2022-10-25

Devices Manufactured by INMODE M.D LTD

• 07290019863083 - Morpheus8 Resurfacing TIP: 2024-08-30 Morpheus8 Resurfacing 24pin TIP
• 07290019863090 - Morpheus8 Prime 12 pin TIP: 2024-08-30 Morpheus8 Prime 12pin Tip
• 07290019863106 - Morpheus8 40 pin TIP: 2024-08-30 Morpheus8 - 40 Pin TIP
• 07290019863113 - Morpheus8 24 pin TIP: 2024-08-30 Morpheus8 - 24 Pin TIP
• 07290019863120 - Morpheus8 Burst Applicator: 2024-08-29 Morpheus8 Burst Applicator ( BLK)
• 07290019863137 - Morpheus8 Burst Deep Applicator: 2024-08-29 Morpheus8 Burst Deep Applicator (BLUE_BLK)
• 07290019863144 - Lumecca Peak: 2024-08-23 Lumecca Peak (Lumecca 515 BLK)
• 07290019863151 - Lumecca Peak: 2024-08-23 Lumecca Peak (Lumecca 580 BLK)