Profound Matrix

GUDID 00817495023724

Candela Corporation

Multi-modality skin surface treatment system

• Primary Device ID: 00817495023724
• NIH Device Record Key: 9fabba86-bd14-4bd1-86d4-a13a1253557a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Profound Matrix
• Version Model Number: FG71841
• 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	00817495023724 [Primary]
GS1	07290109952949 [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: 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: 2022-09-15

On-Brand Devices [Profound Matrix]

• 07290109952949: FG71841
• 00817495023724: FG71841