FSE Pro Series Delivery System 7122-57-9401

GUDID 00817495022529

Delivery System Assembly

CANDELA CORPORATION

Dermatological solid-state laser system

• Primary Device ID: 00817495022529
• NIH Device Record Key: eef10b78-594b-4372-9a08-9496d8ab1b36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FSE Pro Series Delivery System
• Version Model Number: 7122-57-9401
• Catalog Number: 7122-57-9401
• 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	00817495022529 [Primary]
GS1	08174950202523 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140732

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: 5
• Public Version Date: 2020-06-23
• Device Publish Date: 2016-10-03

On-Brand Devices [FSE Pro Series Delivery System]

• 08174950202523: Delivery System Assembly
• 00817495022529: Delivery System Assembly