Copper Bromide Laser

GUDID B241D10B0

The Dual Yellow laser is indicated for the treatment of benign pigmented and cutaneous vascular lesions. The Dual Yellow laser, operating at 578 nm, i

NORSELD PTY. LIMITED

Laser skin surface treatment system applicator

• Primary Device ID: B241D10B0
• NIH Device Record Key: 23848235-75f8-4418-a154-2544469486ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Copper Bromide Laser
• Version Model Number: D10B Dual Yellow
• Company DUNS: 756169231
• Company Name: NORSELD PTY. LIMITED
• 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
HIBCC	B241D10B0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032397

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: 2016-09-21