Cellfina

GUDID 00840763100537

ULTHERA, INC.

Mechanical skin contouring system injection/transection set Mechanical skin contouring system injection/transection set Mechanical skin contouring system injection/transection set Mechanical skin contouring system injection/transection set Mechanical skin contouring system injection/transection set Mechanical skin contouring system injection/transection set Mechanical skin contouring system injection/transection set

• Primary Device ID: 00840763100537
• NIH Device Record Key: 26315dd2-aa54-49dc-b278-b5e224ad4b00
• Commercial Distribution Discontinuation: 2016-09-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cellfina
• Version Model Number: CK1-EU Rev A
• Company DUNS: 010981554
• Company Name: ULTHERA, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00840763100537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153677

FDA Product Code

• OUP: Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-14

Devices Manufactured by ULTHERA, INC.

• 10840763100107 - Cellfina System Procedure Kit (Single Package): 2024-05-09
• 00840763101145 - Ulthera System Control Unit PRIME: 2024-04-18
• 00840763101152 - Ulthera System Handpiece: 2024-04-16
• 00840763100742 - Cellfina Motor Module Device and Package: 2020-02-03
• 00840763100025 - Ulthera System Transducer DS 7-3.0: 2019-07-26
• 00840763100414 - Cellfina System Disposable Tray: 2019-07-26
• 00840763100520 - Cellfina System Disposable Tray: 2019-07-26
• 00840763100612 - Cellfina System Disposable Tray: 2019-07-26