GMAX Pro Plus Laser System 9914-CH-9036

GUDID 00817495024660

GMAX Pro Plus Laser System

Candela Corporation

Dermatological solid-state laser system

• Primary Device ID: 00817495024660
• NIH Device Record Key: 8443f040-e926-4209-947f-127c3b9adfc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMAX Pro Plus Laser System
• Version Model Number: 9914-CH-9036
• Catalog Number: 9914-CH-9036
• 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	00817495024660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201111

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-02
• Device Publish Date: 2024-09-24

On-Brand Devices [GMAX Pro Plus Laser System]

• 00817495024660: GMAX Pro Plus Laser System
• 00817495023571: GMAX Pro Plus Laser System