Alexandrite & Long Pulsed Nd:YAG Laser

GUDID 08809578390344

IDS Ltd

General/multiple surgical frequency-doubled solid-state laser system

• Primary Device ID: 08809578390344
• NIH Device Record Key: 96ae91b1-3d05-4470-b631-e7961d74d345
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alexandrite & Long Pulsed Nd:YAG Laser
• Version Model Number: SMARTRION COMBI
• Company DUNS: 689046045
• Company Name: IDS Ltd
• 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: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr
• Phone: +82220251153
• Email: info@ids.co.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809578390344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222485

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: 2023-04-17
• Device Publish Date: 2023-04-07

Devices Manufactured by IDS Ltd

• 08809578390313 - Picosecond Nd:YAG Laser: 2024-01-05
• 08809578390344 - Alexandrite & Long Pulsed Nd:YAG Laser: 2023-04-17
• 08809578390344 - Alexandrite & Long Pulsed Nd:YAG Laser: 2023-04-17
• 08809578390030 - Phototherapy Unit: 2021-10-19
• 08809578390016 - Q-Switched Nd:YAG Laser: 2019-06-11