Secret DUO Bigger Handpiece

GUDID 08800023201239

ILOODA.CO.,LTD

Dermatological diode laser system

• Primary Device ID: 08800023201239
• NIH Device Record Key: af4249de-697a-4d8d-a195-2be040ef4720
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Secret DUO Bigger Handpiece
• Version Model Number: Secret DUO
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800023201239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213250

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: 2023-09-07
• Device Publish Date: 2023-08-30

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
• 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