Long Pulsed Laser

GUDID 08800088900009

ELEMENIC CO.,LTD.

Dermatological solid-state laser system

• Primary Device ID: 08800088900009
• NIH Device Record Key: 66ce4776-b25a-4cb0-be16-c38e9bcd5c91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Long Pulsed Laser
• Version Model Number: ELEMENT-TL
• Company DUNS: 694716279
• Company Name: ELEMENIC CO.,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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800088900009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180224

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: 2023-04-07
• Device Publish Date: 2023-03-30