FIBER, STANDARD, HC, GMPP 7123-CE-0658

GUDID 00817495023243

CANDELA CORPORATION

Dermatological solid-state laser system

• Primary Device ID: 00817495023243
• NIH Device Record Key: 84bb7ab6-b3f6-48d3-8019-22ae8d1daa4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIBER, STANDARD, HC, GMPP
• Version Model Number: 7123-CE-0658
• Catalog Number: 7123-CE-0658
• 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	00817495023243 [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 [FIBER, STANDARD, HC, GMPP]

• 00817495023243: 7123-CE-0658
• 00817495025186: Fiber Assembly
• 00817495025155: Fiber Assembly
• 00817495024257: Fiber Assembly