QuRAS Fractional H/P

GUDID 08800023200287

QND Fractional H/P

ILOODA.CO.,LTD

Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 08800023200287
• NIH Device Record Key: efc80c88-2da0-4426-bd9a-a876a5c13cff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuRAS Fractional H/P
• Version Model Number: QND Fractional H/P
• Company DUNS: 631129749
• Company Name: ILOODA.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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com
• Phone: +821091905072
• Email: charles.jeong@ilooda.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800023200287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173038

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: 4
• Public Version Date: 2021-08-24
• Device Publish Date: 2018-01-16

Devices Manufactured by ILOODA.CO.,LTD

• 08800023200942 - Secret DUO Main Unit: 2023-09-07
• 08800023200959 - Secret DUO Standard Handpiece: 2023-09-07
• 08800023201239 - Secret DUO Bigger Handpiece: 2023-09-07
• 08800023201390 - Secret DUO Laser Handpiece: 2023-09-07
• 08800023202168 - reepot Main Unit: 2023-09-07
• 08800023202175 - reepot Handpiece: 2023-09-07
• 08800023200218 - VIKINI Main Unit: 2023-06-19
• 08800023200225 - VIKINI Laser H/P: 2023-06-19 DET Laser H/P