Powered Laser Surgical Instrument－APOLLO IV+ Medic

GUDID 06970285176025

Beijing Syntech Laser Co., Ltd.

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

• Primary Device ID: 06970285176025
• NIH Device Record Key: 66a2056b-bac7-4c6e-bcd0-572f5ea4f70c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powered Laser Surgical Instrument－APOLLO IV+ Medic
• Version Model Number: MLP-02
• Company DUNS: 528741132
• Company Name: Beijing Syntech Laser 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970285176025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113018

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-30

On-Brand Devices [Powered Laser Surgical Instrument－APOLLO IV+ Medic]

• 06970285176148: MLP-10
• 06970285176025: MLP-02