Nordlys Mini

GUDID 00817495023960

Nordlys Mini Laser System

Candela Corporation

Multi-modality skin surface treatment system generator

• Primary Device ID: 00817495023960
• NIH Device Record Key: bdd89fdf-1e7b-47e4-a852-697eaabf6597
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nordlys Mini
• Version Model Number: 9SYS7853
• 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	00817495023960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212492

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: 2025-03-18
• Device Publish Date: 2025-03-10

Devices Manufactured by Candela Corporation

• 00817495023960 - Nordlys Mini: 2025-03-18Nordlys Mini Laser System
• 00817495023960 - Nordlys Mini: 2025-03-18 Nordlys Mini Laser System
• 00817495023526 - 1940 Applicator: 2025-03-14 1940 applicator (1940 nm) for Nordlys and Nordlys Mini
• 00817495023953 - 1550 Applicator: 2025-03-14 1550 Applicator (1550 nm) for Nordlys and Nordlys Mini
• 00817495024059 - Vbeam Prima Pro Laser System: 2025-01-23 Vbeam Prima Pro Laser System Nd: YAG Configuration 1064, 595, DCD
• 00817495025247 - Vbeam Prima Pro DCD Handpiece: 2025-01-23 ASSY, DCD HP, DELIVERY SYSTEM, VBEAM PRIMA PRO
• 00817495024677 - PicoWay Laser System: 2024-10-21 PicoWay Laser System
• 00817495023540 - PicoWay Laser System: 2024-10-14 Picoway Laser System
• 00817495023663 - PicoWay Laser System: 2024-10-14 Picoway Laser System