Polylase Polylase MX

GUDID 00860002307046

Dual Output Pulsed Alexandrite and Nd:YAG Laser

DDC TECHNOLOGIES, INC.

Dermatological solid-state laser system

• Primary Device ID: 00860002307046
• NIH Device Record Key: 4274030e-adc3-4bac-9ced-f9c4172dc4b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polylase
• Version Model Number: MX
• Catalog Number: Polylase MX
• 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	00860002307046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040055

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

On-Brand Devices [Polylase]

• 90860002307018: Pulsed Alexandrite Laser
• 00860002307046: Dual Output Pulsed Alexandrite and Nd:YAG Laser
• 00860002307008: Dual Output Pulsed Alexandrite and Nd:YAG Laser