SubQ applicator FG71501

GUDID 00817495024240

SubQ applicator, Packaged, Profound

Candela Corporation

Multi-modality skin surface treatment system

• Primary Device ID: 00817495024240
• NIH Device Record Key: 696092fe-1b01-4fa6-ba13-244ea007ce50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SubQ applicator
• Version Model Number: FG71501
• Catalog Number: FG71501
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495024240 [Primary]
GS1	07290109952079 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161043

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2023-10-30
• Device Publish Date: 2023-10-20

Devices Manufactured by Candela Corporation

• 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