Diode Laser System Deep Tissue Handpiece 6400311

GUDID 00647529003824

A reusable topical heating device intended for use with Diode Laser Systems in pain therapy. The device is used with disposable protective shields.

Biolase, Inc.

Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional

• Primary Device ID: 00647529003824
• NIH Device Record Key: ae29ccaf-e222-4201-b794-3e174d8d2355
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diode Laser System Deep Tissue Handpiece
• Version Model Number: Deep Tissue Handpiece Kit
• Catalog Number: 6400311
• Company DUNS: 152165700
• Company Name: Biolase, Inc.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529003824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121286

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2023-06-27
• Device Publish Date: 2023-06-19

On-Brand Devices [Diode Laser System Deep Tissue Handpiece ]

• 00647529002537: A reusable topical heating device intended for use with Diode Laser Systems in pain therapy. Th
• 00647529000212: A reusable topical heating device intended for use with Diode Laser Systems in pain therapy. The
• 00647529003824: A reusable topical heating device intended for use with Diode Laser Systems in pain therapy. The