Data / Medical devices / United States / Sunoptic Technologies, LLC
Sunoptic Technologies, LLC: FDA-registered device maker in Jacksonville, FL, United States, 9 510(k) clearances
Sunoptic Technologies, LLC is registered with the FDA (registration 1035968) in Jacksonville, FL, United States. It lists 17 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 18, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1035968
- Address
- 6018 Bowdendale Ave., Jacksonville, FL, United States, 32216
- Owner or operator
- SUNOPTIC TECHNOLOGIES, LLC (1035968)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 8, 1992
- Registered through
- 2026
- Brand names listed
- BRAND, Cuda, Customer Brand, Customer brand, DPLS-01, Xenon Lightsource, FIBEROPTIC, FIBEROPTIC HEADLIGHT SYSTEM, FOR ENDOSCOPE and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 18, 2010 | K093792 | LED LIGHT SOURCE | FCW | Substantially Equivalent | Sunoptic Technologies, LLC | accessdata.fda.gov |
| June 23, 2000 | K001223 | ACULUX, MODEL AX3001, AX3002 | FQP | Substantially Equivalent | Aculux | accessdata.fda.gov |
| April 1, 1998 | K980166 | LIGHTSOURCE OR ILLUMINATOR | HET | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
| April 30, 1996 | K961074 | LIGHTSOURCE OR ILLUMINATOR | FSS | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
| November 18, 1993 | K934337 | CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE | FSW | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
| June 18, 1990 | K901491 | CUDA SURGICAL LIGHT | FST | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
| April 23, 1990 | K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE | FST | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
| June 22, 1989 | K893491 | MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300 | FST | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
| June 22, 1989 | K893458 | FIBEROPTIC HEADLIGHT SYSTEM | EBA | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Light, Surgical, Floor Standing
- All makers of Light, Surgical, Fiberoptic
- All makers of Light, Surgical, Carrier
- All makers of Camera, Television, Endoscopic, Without Audio
- All makers of Source, Carrier, Fiberoptic Light
- All makers of Camera, Surgical And Accessories
Updated March 18, 2010. 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.