ZHEONE

GUDID 06977620360026

The Q-Switched Nd:Yag laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.

Hebei Zhemai Technology Co., Ltd.

Multi-modality skin surface treatment system generator

• Primary Device ID: 06977620360026
• NIH Device Record Key: 5ea6f4b1-886c-4125-a11f-bdbfb0eba0ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZHEONE
• Version Model Number: FQ-L08
• Company DUNS: 715544310
• Company Name: Hebei Zhemai Technology 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06977620360026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232716

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: 2024-09-27
• Device Publish Date: 2024-09-19

On-Brand Devices [ZHEONE]

• 06977620360026: The Q-Switched Nd:Yag laser is indicated for the treatment of: benign cutaneous lesions, such as
• 06977620360019: The Intense pulsed light therapy device is indicated for use in surgical and aesthetic applicati
• 06977620360002: The Diode laser therapy device is intended for hair removal, permanent hair reduction on all ski