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Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
FDA product code NHN · Class 2 · Physical Medicine
56
Registered devices
4
Adverse events
7
Recalls
54
510(k) clearances
Devices with this code
ML 830® — MICROLIGHT CORPORATION OF AMERICALEP 2000 Photonic Therapy System — IMI Healing Technologies IncMain Controller Unit (MCU) — Meditech International IncCollagentex Series — Tanses Technologies IncML 830® — MICROLIGHT CORPORATION OF AMERICAML 830® — MICROLIGHT CORPORATION OF AMERICAML 830® — MICROLIGHT CORPORATION OF AMERICAML 830® — MICROLIGHT CORPORATION OF AMERICALD-I 200+ — Meditech International IncLEP 2000 Photonic Therapy System — IMI Healing Technologies IncGlobTek — MICROLIGHT CORPORATION OF AMERICAML 830® — MICROLIGHT CORPORATION OF AMERICATherapy US (FDA) — DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDAML 830® — MICROLIGHT CORPORATION OF AMERICACollagentex Series — Tanses Technologies IncLaserTouchOne — Laser Health Technologies, LLCTherapy EC (FDA) — DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDAVLS — ERCHONIA CORPORATION, LLCBase Station — ERCHONIA CORPORATION, LLCLEP 2000 Photonic Therapy System — IMI Healing Technologies IncLASPOT — Wuhan Guangdun Technology Co.,Ltd.ML 830® — MICROLIGHT CORPORATION OF AMERICAFX635 — ERCHONIA CORPORATION, LLCLEP 2000 Photonic Therapy System — IMI Healing Technologies Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-09-26 | Theralase Inc. | Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard |
| 2019-09-26 | Theralase Inc. | 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 re |
| 2019-09-26 | Theralase Inc. | 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-60 |
| 2019-09-26 | Theralase Inc. | 905 nm laser diodes may be below rated power output. |
| 2019-09-26 | Theralase Inc. | 660 nm laser diodes may be below rated power output. |
| 2019-09-26 | Theralase Inc. | Device was shipped without a Unique Device Identification (UDI) label. |
| 2019-09-26 | Theralase Inc. | 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 specifi |
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