Holinwon 30, HolinWON Prima

GUDID 08800022303309

Holmium Laser

WONTECH CO.,LTD

General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system

• Primary Device ID: 08800022303309
• NIH Device Record Key: ec3f604f-73d5-4b92-b676-929a759cf7f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Holinwon 30, HolinWON Prima
• Version Model Number: Holinwon 30, HolinWON Prima
• 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	08800022303309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183563

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

Devices Manufactured by WONTECH CO.,LTD

• 08800022305327 - Oligio X: 2024-03-29 Radio Frequency Therapy System
• 08800022305914 - PICOANDY: 2024-03-29 Q-switched Nd:YAG Laser
• 08800022303620 - Air Gap Fiber: 2024-02-13 AG275 of Air Gap Fiber Series AG550, AG365, AG275
• 08800022303606 - Air Gap Fiber: 2024-02-09 AG550 of Air Gap Fiber Series AG550, AG365, AG275
• 08800022303613 - Air Gap Fiber: 2024-02-09 AG365 of Air Gap Fiber Series AG550, AG365, AG275
• 08800022301107 - Lavieen: 2023-09-28 Tm-doped Fiber Laser System
• 08800022304016 - ALMA VEIL; V-Laser: 2023-09-01 Q-switched Nd:YAG Laser
• 08800022303309 - Holinwon 30, HolinWON Prima: 2023-03-01Holmium Laser
• 08800022303309 - Holinwon 30, HolinWON Prima: 2023-03-01 Holmium Laser