Data / Medical devices / Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy (NHN): 20 FDA-registered makers in 6 countries
20 establishments in 6 countries are registered with the FDA to make Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy (product code NHN, Class 2, 21 CFR 890.5500). 15 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 54 510(k) clearances under this code, the latest on May 19, 2026, and lists 6 recall events (0 Class I). FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- NHN
- Device class
- 2
- Regulation
- 890.5500
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 5 |
| Canada | 4 |
| Switzerland | 2 |
| Japan | 2 |
| Brazil | 1 |
Makers of Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Erchonia Corporation | Fountain Inn, SC, United States | Complaint file establishment, Manufacturer, Remanufacturer | 10 | September 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Medical Quant Usa | Solon, OH, United States | Manufacturer, Repackager or relabeler | 3 | May 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| DMC Importacao E Exportacao De Equipamentos Ltda | Sao Carlos Sao Paulo, Brazil | Manufacturer | 2 | December 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| MedX Health Corp. | MISSISSAUGA Ontario, Canada | Manufacturer | 2 | March 24, 2003 | 0 | 0 | 0 | api.fda.gov |
| Tanses Technologies, Inc. | FABREVILLE Quebec, Canada | Manufacturer | 2 | May 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Theralase Technologies Inc. | Toronto Ontario, Canada | Manufacturer | 2 | November 19, 2015 | 0 | 6 | 0 | api.fda.gov |
| Bioptron AG | WOLLERAU Schwyz, Switzerland | Exporter to the US, Specification developer | 1 | February 4, 2004 | 0 | 0 | 0 | api.fda.gov |
| Bioptron AG | Neuchatel, Switzerland | Manufacturer | 1 | February 4, 2004 | 0 | 0 | 0 | api.fda.gov |
| Hubei Yjt Intelligent Technology Group Co., Ltd. | Wuhan Hubei, China | Manufacturer | 1 | February 6, 2002 | 0 | 0 | 0 | api.fda.gov |
| Microlight Corporation Of America | Missouri City, TX, United States | Specification developer | 1 | February 6, 2002 | 0 | 0 | 0 | api.fda.gov |
| Meditech International Inc | Toronto Ontario, Canada | Manufacturer | 1 | April 2, 2008 | 0 | 0 | 0 | api.fda.gov |
| Rhein Laser Technologies Co., Ltd. | wuhan Hubei, China | Complaint file establishment, Manufacturer | 1 | November 25, 2003 | 0 | 0 | 0 | api.fda.gov |
| Seic Shenzhen Shinelong Electronics Industrial Co. | Long Gang District,, SHENZHEN Guangdong, China | Contract manufacturer, Exporter to the US | 1 | February 6, 2002 | 0 | 0 | 0 | api.fda.gov |
| Wuhan Guangdun Technology Co.,ltd | WUHAN Hubei, China | Manufacturer | 1 | January 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Wuhan Lotuxs Technology Co.,ltd. | Wuhan Hubei, China | Complaint file establishment, Manufacturer | 1 | November 25, 2003 | 0 | 0 | 0 | api.fda.gov |
| Hair Laser Manufacturing, LLC | Southlake, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ITI Manufacturing Inc. | Sugar Land, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KETAKA ELECTRIC Co.,Ltd. | Tottori, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laser Health Technologies | Paradise Valley, AZ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ya-Man Ltd. | Koto-ku Tokyo, Japan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.