SURGITRON 4.0 DUAL RF/120 IEC 220V

GUDID 00841494108465

SURGITRON 4.0 DUAL RF/120 IEC 220V

Cynosure, Inc.

Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system

• Primary Device ID: 00841494108465
• NIH Device Record Key: 60510346-de1b-4580-b704-bbf43357a015
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGITRON 4.0 DUAL RF/120 IEC 220V
• Version Model Number: IEC3A-S30/220
• Company DUNS: 780318028
• Company Name: Cynosure, Inc.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841494108465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013255

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: 2019-05-13
• Device Publish Date: 2019-05-03

Devices Manufactured by Cynosure, Inc.

• 00841494108090 - ASSY, FOCUS ARRAY, PLATINUM, PICOSURE: 2022-08-16 ASSY, FOCUS ARRAY, PLATINUM, PICOSURE
• 00841494103507 - Vectus - Base Module Reman: 2022-08-15 Vectus - Base Module Reman
• 00841494103774 - ICON CONTROL MODULE REMAN: 2022-08-15 ICON CONTROL MODULE REMAN
• 00841494100230 - ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300: 2021-08-13 ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300
• 00841494100537 - ASSY, FINAL LASER, PICO300: 2021-08-13 ASSY, FINAL LASER, PICO300
• 00841494100520 - ASSY, 1540 HANDPIECE, ICON: 2021-07-26 ASSY, 1540 HANDPIECE, ICON
• 00841494102272 - 1540 HANDPIECE ICON, REMANUFACTURED: 2021-07-26 1540 HANDPIECE ICON, REMANUFACTURED
• 00841494105105 - 60MM HANDPIECE W/ACC, TEMPSURE: 2021-07-26 60MM HANDPIECE W/ACC, TEMPSURE