AL-40 AL-40

GUDID 00860002307022

Pulsed Alexandrite Laser

DDC TECHNOLOGIES, INC.

Dermatological solid-state laser system

• Primary Device ID: 00860002307022
• NIH Device Record Key: 39cfc0f2-9c68-4ff3-8fd5-c49910b0d761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AL-40
• Version Model Number: AL-40
• Catalog Number: AL-40
• Company DUNS: 128532707
• Company Name: DDC TECHNOLOGIES, 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: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 516-5941533
• Email: sales@ddctech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002307022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010715

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: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-12-09

Devices Manufactured by DDC TECHNOLOGIES, INC.

• 00860002307008 - Polylase: 2020-02-06 Dual Output Pulsed Alexandrite and Nd:YAG Laser
• 00860002307022 - AL-40: 2020-02-06Pulsed Alexandrite Laser
• 00860002307022 - AL-40: 2020-02-06 Pulsed Alexandrite Laser
• 00860002307039 - EPY-50: 2020-02-06 Pulsed Nd:YAG Laser
• 00860002307046 - Polylase: 2020-02-06 Dual Output Pulsed Alexandrite and Nd:YAG Laser
• 90860002307018 - Polylase: 2020-02-06 Pulsed Alexandrite Laser