GentleMAX PRO PLUS Laser System 9914-CE-9036

GUDID 00817495023120

CANDELA CORPORATION

Dermatological solid-state laser system

• Primary Device ID: 00817495023120
• NIH Device Record Key: 04def143-d5fa-45a3-b19d-8febcdcc017e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GentleMAX PRO PLUS Laser System
• Version Model Number: 9914-CE-9036
• Catalog Number: 9914-CE-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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495023120 [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: 2022-01-25
• Device Publish Date: 2022-01-17

On-Brand Devices [GentleMAX PRO PLUS Laser System]

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