UltraShape System, Packaged for US FG71052US

GUDID 07290109952451

UltraShape System, Packaged for US

SYNERON MEDICAL LTD

Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system Ultrasonic body contouring system

• Primary Device ID: 07290109952451
• NIH Device Record Key: e00d2090-e4dd-40cd-ab14-673f42b6fa3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraShape System, Packaged for US
• Version Model Number: FG71052US
• Catalog Number: FG71052US
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109952451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141708

FDA Product Code

• OHV: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

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: 2017-01-17

Devices Manufactured by SYNERON MEDICAL LTD

• 07290109952703 - SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III: 2020-03-31 SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
• 07290109952857 - Intima Sterile 2 Internal + 1 External HP, Accessories Kit: 2020-02-10 Intima Sterile 2 Internal + 1 External HP, Accessories Kit
• 07290109952864 - eTwo System: 2020-02-10 eTwo System
• 17290109952724 - Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima: 2020-02-10 Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
• 17290109952823 - External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima: 2020-02-10 External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
• 17290109950379 - Internal, CO2RE Intima: 2019-02-07 Internal, CO2RE Intima
• 07290109950167 - Purple swivel lens: 2019-02-07 Purple swivel lens
• 07290109950273 - Lens, Gold & Silver: 2019-02-07 Lens, Gold & Silver Assy, CO2RE