Lasermach PRO Handpiece

GUDID 06972590500021

Diode Laser Therapy Systems Handpiece

Wingderm Electro-Optics Ltd.

Dermatological diode laser system

• Primary Device ID: 06972590500021
• NIH Device Record Key: daad6d20-1a61-4be1-80d6-7fc7796c1009
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lasermach PRO Handpiece
• Version Model Number: WLA-01
• Company DUNS: 554477467
• Company Name: Wingderm Electro-Optics 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	06972590500021 [Primary]
GS1	26972590500025 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191611

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: 2019-12-24
• Device Publish Date: 2019-12-16

On-Brand Devices [Lasermach PRO Handpiece]

• 16972590500028: Diode Laser Therapy Systems Handpiece
• 06972590500021: Diode Laser Therapy Systems Handpiece
• 06972978060024: Diode Laser Therapy Systems Handpiece