Pastelle Pro

GUDID 08800022302906

Q-switched Nd:YAG Laser

WONTECH CO.,LTD

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

• Primary Device ID: 08800022302906
• NIH Device Record Key: c939d951-af4a-4b21-a050-a899d655b3ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pastelle Pro
• Version Model Number: Pastelle Pro
• 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	08800022302906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241527

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: 2025-03-04
• Device Publish Date: 2025-02-24

Devices Manufactured by WONTECH CO.,LTD

• 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: 2025-03-04Q-switched Nd:YAG Laser
• 08800022302906 - Pastelle Pro: 2025-03-04 Q-switched Nd:YAG Laser
• 08800022301404 - Veincare: 2024-12-25 Surgical Diode Laser System
• 08800022301121 - NOUVADerm: 2024-10-14 Tm-doped Fiber Laser System
• 08800022305327 - Oligio X: 2024-03-29 Radio Frequency Therapy System