Focal 44 Sublative iD (200 Pulses), 10 Pack

GUDID 00817495023762

CANDELA CORPORATION

Multi-modality skin surface treatment system

• Primary Device ID: 00817495023762
• NIH Device Record Key: ea29894e-62e1-4173-92b0-f267837e6c2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Focal 44 Sublative iD (200 Pulses), 10 Pack
• Version Model Number: KT72962
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00817495023762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141507
• Premarket Notification: K211217

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-28
• Device Publish Date: 2022-09-20

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