GentleMAX PRO PLUS Laser System

GUDID 00817495024127

GentleMax Pro Plus Laser System

Candela Corporation

Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system

• Primary Device ID: 00817495024127
• NIH Device Record Key: 1c15675d-164e-4929-96af-576383777ce7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GentleMAX PRO PLUS Laser System
• Version Model Number: 9914-00-9036
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495024127 [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: 2022-12-13
• Device Publish Date: 2022-12-05

On-Brand Devices [GentleMAX PRO PLUS Laser System]

• 00817495023120: 9914-CE-9036
• 00817495024127: GentleMax Pro Plus Laser System