Theralase

GUDID 00627987397475

Cool Laser Therapy System

Theralase Inc

Musculoskeletal/physical therapy laser, professional

• Primary Device ID: 00627987397475
• NIH Device Record Key: b381478a-5914-4282-9860-848c64bcdeff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Theralase
• Version Model Number: TLC-2000
• Company DUNS: 258595334
• Company Name: Theralase Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	00627987397475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151816

FDA Product Code

• NHN: Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

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: 2023-11-06
• Device Publish Date: 2023-10-27

On-Brand Devices [Theralase]

• 00627987397475: Cool Laser Therapy System
• 00627987397499: Therapeutic Laser System