Frax Pro

GUDID 00817495023465

Frax Pro

CANDELA CORPORATION

Multi-modality skin surface treatment system

• Primary Device ID: 00817495023465
• NIH Device Record Key: 2b3d440f-9ac6-4c9f-8a07-b206c3389018
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Frax Pro
• Version Model Number: 9SYS7852-001-CNDL
• 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	00817495023465 [Primary]

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: 2021-01-25
• Device Publish Date: 2021-01-15

Devices Manufactured by CANDELA CORPORATION

• 00817495025070 - Refurbished Applicator Frax 1550: 2025-05-28 Refurbished Applicator Frax 1550
• 00817495025087 - Refurbished Applicator Frax 1940: 2025-05-28 Refurbished Applicator Frax 1940
• 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