Large Spot Fiber Assembly

GUDID 00817495021317

Fiber Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator

• Primary Device ID: 00817495021317
• NIH Device Record Key: 91769485-02d0-4aa9-bb0d-68c86b187b6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Large Spot Fiber Assembly
• Version Model Number: 7122-00-9746
• 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	00817495021317 [Primary]
GS1	08174950201311 [Previous]

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-06-12
• Device Publish Date: 2016-09-23

On-Brand Devices [Large Spot Fiber Assembly]

• 00817495021317: Fiber Assembly
• 00817495025193: Fiber Assembly
• 00817495025162: Fiber Assembly
• 00817495024332: Fiber Assembly