CO2RE Intima

GUDID 00817495025063

External Handpiece Sterile Single-Use, Blister Packaged, CO2RE Intima

Candela Corporation

Dermatological laser beam guiding handpiece

• Primary Device ID: 00817495025063
• NIH Device Record Key: 8b74ae08-f0a7-4dc9-81fb-5dd6bbce89cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO2RE Intima
• Version Model Number: AS95201
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00817495025063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181523

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-30
• Device Publish Date: 2023-10-20

On-Brand Devices [CO2RE Intima]

• 00817495025063: External Handpiece Sterile Single-Use, Blister Packaged, CO2RE Intima
• 00817495024417: Hand Piece Internal hygienic, Packaged, CO2RE Intima