FSE, PicoWay 785nm Handpiece

GUDID 08174950202721

Handpiece Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator

• Primary Device ID: 08174950202721
• NIH Device Record Key: b115ce16-7f0a-4c43-b336-3b7389779942
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FSE, PicoWay 785nm Handpiece
• Version Model Number: 7123-57-0191
• 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

Customer Support Contacts

• Phone: 800-733-8550
• Email: customer.service@candelamedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08174950202721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191685

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: 2019-12-20
• Device Publish Date: 2019-12-12

On-Brand Devices [FSE, PicoWay 785nm Handpiece]

• 08174950202721: Handpiece Assembly
• 08174950227212: Handpiece Assembly
• 00817495027210: Handpiece Assembly