Alex TriVantage Delivery System

GUDID 00817495022154

Delivery System Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece

• Primary Device ID: 00817495022154
• NIH Device Record Key: 33bb49fc-67b5-4fe5-a8a0-c900043b1002
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alex TriVantage Delivery System
• Version Model Number: 7122-00-0921
• 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	00817495022154 [Primary]
GS1	08174950202158 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081324

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: 4
• Public Version Date: 2020-06-17
• Device Publish Date: 2016-09-23

On-Brand Devices [Alex TriVantage Delivery System]

• 00817495020518: Delivery System Assembly
• 00817495022154: Delivery System Assembly