SWOT

GUDID 06972693080017

Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

Multi-modality skin surface treatment system

• Primary Device ID: 06972693080017
• NIH Device Record Key: 1ecf7415-1a71-4f7a-b678-db75b43fa7b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SWOT
• Version Model Number: 001
• Company DUNS: 723541293
• Company Name: Shanghai Wonderful Opto-Electrics Tech.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	06972693080017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163655

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: 2019-10-02
• Device Publish Date: 2019-09-24

On-Brand Devices [SWOT]

• 06972693080017: 001
• 06972693080024: 002
• 06972693080031: 003