VIKINI Main Unit DET Main Unit

GUDID 08800023200218

ILOODA.CO.,LTD

Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system

• Primary Device ID: 08800023200218
• NIH Device Record Key: 5c72e7fc-3a8c-4ece-91ad-cdeb240a6f97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIKINI Main Unit
• Version Model Number: DET Main Unit
• Catalog Number: DET Main Unit
• 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
• 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	08800023200218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151232

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: 2023-06-19
• Device Publish Date: 2018-01-15

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
• 08800023200218 - VIKINI Main Unit: 2023-06-19
• 08800023200225 - VIKINI Laser H/P: 2023-06-19 DET Laser H/P