VPYAG-LE 8MM RGD Fiber Assembly 7122-00-7540

GUDID 00817495022512

Delivery System Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator

• Primary Device ID: 00817495022512
• NIH Device Record Key: 0fbe5087-054d-409f-aad5-3f7c94e4152c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VPYAG-LE 8MM RGD Fiber Assembly
• Version Model Number: 7122-00-7540
• Catalog Number: 7122-00-7540
• 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	00817495022512 [Primary]
GS1	08174950202516 [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: 2020-06-23
• Device Publish Date: 2016-10-03

Devices Manufactured by CANDELA CORPORATION

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• 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