CLEANE

GUDID 08809216198103

MEDICON CO., LTD

Blue-light phototherapy lamp, home-use

• Primary Device ID: 08809216198103
• NIH Device Record Key: e46aaa54-add1-4fba-bb95-61cde56d28ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEANE
• Version Model Number: CLEANE
• Company DUNS: 688209532
• Company Name: MEDICON 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809216198103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111341

FDA Product Code

• OZC: Over The Counter Thermal Treatment For Acne.

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: 2020-08-24
• Device Publish Date: 2020-08-15