Veincare

GUDID 08800022301404

Surgical Diode Laser System

WONTECH CO.,LTD

General/multiple surgical diode laser system

• Primary Device ID: 08800022301404
• NIH Device Record Key: e7f096d6-3fb5-48ff-a7eb-7c3d137545c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Veincare
• Version Model Number: Veincare
• 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	08800022301404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241930

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: 2024-12-25
• Device Publish Date: 2024-12-17

Devices Manufactured by WONTECH CO.,LTD

• 08800022304412 - PICOALEX: 2025-04-02 Alexandrite laser System
• 08800022301800 - WONTECH Surgical Optic Fibers: 2025-03-04 BA400 of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)
• 08800022301817 - WONTECH Surgical Optic Fibers: 2025-03-04 BA600 of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)
• 08800022301824 - WONTECH Surgical Optic Fibers: 2025-03-04 BA400R of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)
• 08800022301831 - WONTECH Surgical Optic Fibers: 2025-03-04 BA600R of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)
• 08800022302906 - Pastelle Pro: 2025-03-04 Q-switched Nd:YAG Laser
• 08800022301404 - Veincare: 2024-12-25Surgical Diode Laser System
• 08800022301404 - Veincare: 2024-12-25 Surgical Diode Laser System
• 08800022301121 - NOUVADerm: 2024-10-14 Tm-doped Fiber Laser System