ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZIL

GUDID 00841494107963

ASSY, FINAL LASER, SCULPSURE, SUB ONLY BRAZIL

Cynosure, Inc.

Low-intensity laser fat liquefaction system

• Primary Device ID: 00841494107963
• NIH Device Record Key: 5f101003-a6ed-4aba-9a8a-35c53ce14727
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZIL
• Version Model Number: 100-7026-920
• 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	00841494107963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171992

FDA Product Code

• PKT: Laser for disruption of adipocyte cells for aesthetic use

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: 2017-11-29

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