SmoothSkin

GUDID 06976933650282

Cyden Medical Technology (Zhejiang) Co., Ltd.

Home-use intense pulsed light hair removal unit

• Primary Device ID: 06976933650282
• NIH Device Record Key: 866564f6-7506-46b8-844c-418978811d84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmoothSkin
• Version Model Number: SSB2
• Company DUNS: 601564992
• Company Name: Cyden Medical Technology (Zhejiang) 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	06976933650282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213692

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: 2024-03-04
• Device Publish Date: 2024-02-23