Matrix Pro Cartridge box (pack of 7)

GUDID 47290109952961

Candela Corporation

Multi-modality skin surface treatment system

• Primary Device ID: 47290109952961
• NIH Device Record Key: b5d11653-ff49-4d19-9abd-87769253c2b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Matrix Pro Cartridge box (pack of 7)
• Version Model Number: KT78161
• Company DUNS: 053468385
• Company Name: Candela Corporation
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	47290109952961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211217

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-10-12
• Device Publish Date: 2022-09-16

On-Brand Devices [Matrix Pro Cartridge box (pack of 7)]

• 47290109952961: KT78161
• 00817495023717: KT78161