Refurbished GentleMax Pro 9914-57-9035

GUDID 00817495024097

Refurbished GentleMax Pro

Candela Corporation

Dermatological solid-state laser system

• Primary Device ID: 00817495024097
• NIH Device Record Key: 747c3630-09ed-4514-a072-10a20f52ce65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Refurbished GentleMax Pro
• Version Model Number: 9914-57-9035
• Catalog Number: 9914-57-9035
• 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	00817495024097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140122

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: 2022-12-07
• Device Publish Date: 2022-11-29

On-Brand Devices [Refurbished GentleMax Pro]

• 00817495024103: Refurbished GentleMax Pro
• 00817495024097: Refurbished GentleMax Pro