# K151816: TLC-2000 Therapeutic Medical Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Theralase, Inc.
- Decided: Nov 19, 2015 after 136 days
- Product code: NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Sep 26, 2019 · Class III · Z-0607-2020: Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.
- Sep 26, 2019 · Class III · Z-0606-2020: Device was shipped without a Unique Device Identification (UDI) label.
- Sep 26, 2019 · Class III · Z-1348-2020: Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards
- Sep 26, 2019 · Class III · Z-1354-2020: 905 nm laser diodes may be below rated power output.
- Sep 26, 2019 · Class III · Z-1353-2020: 660 nm laser diodes may be below rated power output.
- Sep 26, 2019 · Class III · Z-1266-2020: Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
- Sep 26, 2019 · Class III · Z-1326-2020: Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Mod

## Indications for use
The Theralase TLC-2000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.

Source page: https://510kreport.com/device/K151816
Methodology: https://510kreport.com/methodology