Internal, CO2RE Intima KT76614US

GUDID 17290109950379

Internal, CO2RE Intima

SYNERON MEDICAL LTD

Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system

• Primary Device ID: 17290109950379
• NIH Device Record Key: e3cb7a8a-d4dc-406a-8404-331eb98395a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Internal, CO2RE Intima
• Version Model Number: KT76614US
• Catalog Number: KT76614US
• Company DUNS: 532685716
• Company Name: SYNERON MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290109950379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151655
• Premarket Notification: K181523

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-26

On-Brand Devices [ Internal, CO2RE Intima]

• 07290109950372: Internal, CO2RE Intima
• 17290109950379: Internal, CO2RE Intima