MISMON

GUDID 06971648210011

Shenzhen Mismon Technology Co.,Ltd

Dermatological diode laser system

• Primary Device ID: 06971648210011
• NIH Device Record Key: e1f5dcdd-c0a8-4903-b10b-f0e0f7efe27a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MISMON
• Version Model Number: MS-206B
• Company DUNS: 544542711
• Company Name: Shenzhen Mismon Technology Co.,Ltd
• Device Count: 100
• 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: true
• 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	06971648210011 [Primary]
GS1	06971648210035 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180016

FDA Product Code

• OHT: Light Based Over-The-Counter Hair Removal

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: 2018-10-19
• Device Publish Date: 2018-09-18