TLC-2000 Therapeutic Medical Laser System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151816 FDA 510(k)
- FDA Product Code
- NHN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5500 FDA 510(k)
- Regulation Number
- 890.5500 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TLC-2000 Therapeutic Medical Laser System is a powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy. It consists of a hand-held multiple laser probe with 5 x 905 nanometer Near Infra Red super-pulsed laser diodes and 4 x 660 nm visible red laser diodes. The device is used for therapeutic purposes, providing up to 200 milliWatts average power each, superpulsed at 100 Watts and pulsed at 300 mW. It is classified as a class 2 device. The device is used in physical medicine.
The TLC-2000 Therapeutic Medical Laser System is supplied as a single unit, with a product code of NHN and a regulation number of 890.5500. It has been authorized with an FDA 510K clearance, with a decision code of SESE and a k number of K151816. The device is intended for use in a medical setting, and its storage and use should be in accordance with the operation manual. The device has a registration number and an FEI number associated with it.
Frequently asked questions
What is the TLC-2000 Laser System used for?
The TLC-2000 is used for adjunctive pain therapy in a medical setting, providing a non-thermal and non-heating effect.
How is the TLC-2000 Laser System supplied?
The TLC-2000 is supplied as a single unit, with a product code of NHN and a regulation number of 890.5500.
Is the TLC-2000 Laser System a single-use or reusable device?
The description does not explicitly state whether the TLC-2000 is single-use or reusable, but it is classified as a class 2 device and has a specific storage and use procedure outlined in the operation manual.
What are the technical specifications of the TLC-2000 Laser System?
The TLC-2000 uses 5 x 905nm and 4 x 660nm laser diodes, with an average power of up to 200mW, superpulsed at 100W and pulsed at 300mW.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Therapeutic Laser Series TLC-2000 - Theralase Technologies, THERALASE TLC-2000 OPERATION MANUAL Pdf Download, THERALASE TLC-2000 SERIES OPERATION MANUAL Pdf Download, Therapeutic Laser Series TLC-2000 - Theralase Technologies
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151816 | Class II | Active |
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Manufacturer
- Manufacturer
- Theralase, Inc.
Sources (1)
- FDA 510(k) K151816 24 fields · synced Oct 6, 2026