PICOCAREMAJESTY

GUDID 08800022305600

Q-switched Nd:YAG Laser

Won Tech Co., Ltd.

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

• Primary Device ID: 08800022305600
• NIH Device Record Key: 0d4b867f-6337-4fc2-a170-0bed67fa5962
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PICOCAREMAJESTY
• Version Model Number: PICOCAREMAJESTY
• 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	08800022305600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212127

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: 2022-02-09
• Device Publish Date: 2022-02-01

Devices Manufactured by Won Tech Co., Ltd.

• 08800022305310 - The Oligio: 2023-02-27 Radio Frequency Therapy System
• 08800022305600 - PICOCAREMAJESTY: 2022-02-09Q-switched Nd:YAG Laser
• 08800022305600 - PICOCAREMAJESTY: 2022-02-09 Q-switched Nd:YAG Laser
• 08800022300803 - Pastelle: 2021-08-24 Q-switched Nd:YAG Laser
• 08800022303200 - Picocare: 2021-08-24 Q-switched Nd:YAG Laser
• 08800022303217 - Picocare Family, Picocare450: 2021-08-24 Q-Switched Nd:YAG Laser
• 08800022304405 - Picowon: 2020-10-14 Alexandrite laser System
• 08800022300209 - Cosjet SR: 2020-02-06 Long Pulse Nd:YAG Laser
• 08800022304917 - Hair Boom69, Hair Boom: 2019-11-05 Low level laser therapy device.