Data / Medical devices / Light, Surgical, Instrument
Light, Surgical, Instrument (FSQ): 22 FDA-registered makers in 8 countries
22 establishments in 8 countries are registered with the FDA to make Light, Surgical, Instrument (product code FSQ, Class 2, 21 CFR 878.4580). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on July 30, 1993, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FSQ
- Device class
- 2
- Regulation
- 878.4580
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| China | 6 |
| Germany | 2 |
| India | 1 |
| Turkey | 1 |
| Switzerland | 1 |
| Spain | 1 |
| South Korea | 1 |
Makers of Light, Surgical, Instrument
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 |
|---|---|---|---|---|---|---|---|---|
| Alira Medical Devices LLC | Rancho Cucamonga, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Medical Systems GmbH + Co. KG | Munich Bavaria, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Medical Systems GmbH + Co. KG | SAALFELD Thuringia, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Kaiser Technology Co., Ltd | Dongguan city Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Etkin Tibbi Cihazlar San. Ve Tic. A.S. | Cigli Izmir, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gyrus Acmi, Inc. | Bartlett, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hill-Rom Company, Inc. | Ladson, SC, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neo Medical S.A. | Villette (Lavaux) Vaud, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Optics Corp. | Gardner, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qufu Lekang Medical Technology Group Co.,ltd. | JINING CITY Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Chenhong Medical Technology Co., Ltd. | JINING CITY Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yinghuada Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Swan Medical SL | Barcelona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Shanglaite Electronic Technology Co. LTD | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viseon, Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Brimfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenosys Co., Ltd. | Incheon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Fude Medphotonic Co.,ltd. | Huzhou City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 30, 1993. 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.