DEKA Motus AX M112B1

GUDID 08057017760221

The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. The laser source delivers the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. Handpiece activation is either by footswitch or fingerswitch.

EL.EN. SPA

Dermatological solid-state laser system

• Primary Device ID: 08057017760221
• NIH Device Record Key: 9b21ffa3-f8db-4c6f-af37-582739e19bf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEKA Motus AX
• Version Model Number: M112B1
• Catalog Number: M112B1
• Company DUNS: 436887608
• Company Name: EL.EN. SPA
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057017760221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162886

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-07-03

Devices Manufactured by EL.EN. SPA

• 08057017760818 - ALLORA PRO: 2024-02-22 The DEKA AGAIN PRO family is a medical laser family equipped with Nd:YAG 1064nm laser. The laser sources deliver the laser outpu
• 08057017760719 - DEKA SCULPT: 2023-05-05 The SCULPT is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneo
• 08057017760726 - DEKA SmartXide UltraSpeed 2: 2023-05-05 DEKA SmartXide UltraSpeed 2 is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser ou
• 08057017760733 - DEKA TRUIST: 2023-05-05 The DEKA TRUIST is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Th
• 08057017760665 - DEKA HELIX: 2023-03-29 The Helix system consists of: • Laser system console (containing the optical bench assembly and laser, the microcontroller con
• 08057017760528 - DEKA SMARTPERIO: 2022-04-13 The DEKA SmartPerio is a Nd:YAG laser device for soft tissues intraoral treatments. The DEKA SmartPerio system delivers laser th
• 08057017760566 - DEKA MOTUS AZ+: 2022-04-13 The DEKA Motus AZ+ is a medical device equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sources deliver
• 08057017760580 - DEKA LIPOAI: 2022-04-13 The LipoAI is medical laser equipped with a short pulse 1444 nm Nd:YAG laser source. The device delivers the laser energy throug