FIBER, STANDARD, HC, GMPP

GUDID 00817495025186

Fiber Assembly

Candela Corporation

Dermatological laser beam producing handpiece

• Primary Device ID: 00817495025186
• NIH Device Record Key: 1b148ef7-9749-4a2c-b5be-1d57534d7e85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIBER, STANDARD, HC, GMPP
• Version Model 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495025186 [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: 2023-07-07
• Device Publish Date: 2023-06-29

On-Brand Devices [FIBER, STANDARD, HC, GMPP]

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