BIOXEL

GUDID 08800042100018

AMI Inc.

Dermatological carbon dioxide laser system

• Primary Device ID: 08800042100018
• NIH Device Record Key: 79a8fcb5-5ed7-4a75-b4a4-bcfaedd8f902
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOXEL
• Version Model Number: BIOXEL
• Company DUNS: 689004697
• Company Name: AMI 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr
• Phone: +82232819091
• Email: amimed@amimed.co.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800042100018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173359

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-23
• Device Publish Date: 2021-06-15

Devices Manufactured by AMI Inc.

• 08800042100001 - Q-MASTER: 2021-06-23
• 08800042100018 - BIOXEL: 2021-06-23
• 08800042100018 - BIOXEL: 2021-06-23