V-Laser

GUDID 08800022304009

Q-switched Nd:YAG Laser

Won Tech Co., Ltd.

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• Primary Device ID: 08800022304009
• NIH Device Record Key: 62e8d5ec-2a8a-4a9f-ba0b-1666b469d8c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-Laser
• Version Model Number: V-Laser
• Company DUNS: 688798565
• Company Name: Won 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800022304009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183156

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: 2019-05-29
• Device Publish Date: 2019-05-21

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