SANDRO Dual

GUDID 08800022304108

The SANDRO Dual Laser System is Nd:YAG and Alexandrite laser system.

WONTECH CO.,LTD

Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system

• Primary Device ID: 08800022304108
• NIH Device Record Key: e2a4f738-6d7e-4bfe-a86e-75084de2af7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SANDRO Dual
• Version Model Number: SANDRO Dual
• Company DUNS: 695658263
• Company Name: WONTECH 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	08800022304108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200110

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-03-01
• Device Publish Date: 2020-06-16

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• 08800022303613 - Air Gap Fiber: 2024-02-09 AG365 of Air Gap Fiber Series AG550, AG365, AG275
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