PicoWay Laser System

GUDID 00817495024677

PicoWay Laser System

Candela Corporation

Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 00817495024677
• NIH Device Record Key: 1d65aa8b-745a-4bdf-8c84-41abe34748fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PicoWay Laser System
• Version Model Number: 9914-CH-9060
• 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: true
• 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	00817495024677 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220853

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: 2024-10-21
• Device Publish Date: 2024-10-11

On-Brand Devices [PicoWay Laser System]

• 00817495023595: Pulse Laser
• 00817495023588: Picoway Laser System
• 00817495023663: Picoway Laser System
• 00817495023540: Picoway Laser System
• 00817495024677: PicoWay Laser System