Forma AG603799A

GUDID 07290016633061

Forma

INMODE M.D LTD

Radio-frequency skin surface treatment system

• Primary Device ID: 07290016633061
• NIH Device Record Key: f8059cf2-bd32-4c0e-b87f-a37a0eead9cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Forma
• Version Model Number: AG603799A
• Catalog Number: AG603799A
• 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	07290016633061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140926

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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

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• 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)