Matrix Pro Applicator, Profound Matrix

GUDID 07290109952956

Candela Corporation

Multi-modality skin surface treatment system

• Primary Device ID: 07290109952956
• NIH Device Record Key: 32e9bb5e-97bd-4587-b105-8812f12afc4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Matrix Pro Applicator, Profound Matrix
• Version Model Number: FG71851
• 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: 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
GS1	07290109952956 [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: false

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 Applicator, Profound Matrix]

• 07290109952956: FG71851
• 00817495023731: FG71851