Matrix Pro Cartridge box (pack of 7)

GUDID 00817495023717

Candela Corporation

Multi-modality skin surface treatment system

• Primary Device ID: 00817495023717
• NIH Device Record Key: a28b4d3f-44a1-4907-a44a-49e692bf574f
• 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: true
• 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	00817495023717 [Primary]
GS1	47290109952961 [Previous]

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