Manufacturer registered with FDA
Sunoptic Technologies LLC
Jacksonville, FL, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1573 registrations outside the US
- Establishments
- 1United States
Registered in 15 markets
Where regulators' registries name Sunoptic Technologies LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Sunoptic Technologies LLC | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Sunoptic Technologies, LLCSUNOPTIC TECHNOLOGIES · Sunoptic Technologies · +2 | 24 | 2003–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SUNOPTIC TECHNOLOGIES, LLCSUNOPTIC TECHNOLOGIES | 10 | 2006–2018 | Pure Global AI |
| Australia | TGA | Manufacturer | Sunoptic Technologies LLC | 9 | 2004–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | SUNOPTIC TECHNOLOGIES LLC | 5 | 2025–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Sunoptic Technologies, LLCSunoptic Technologies LLC | 5 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SUNOPTIC TECHNOLOGIES LLC | 4 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Sunoptic Technologies, LLC | 4 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Sunoptic Technologies, LLC | 3 | 2022–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SUNOPTIC TECHNOLOGIES, LLC | 2 | 2008–2011 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SUNOPTIC TECHNOLOGIES LLCSUNOPTIC TECHNOLOGIES, LLC. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Sunoptic TechnologiesSunoptic Technologies, LLC | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 奥普光学科技有限公司Sunoptic Technologies,LLC | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Sunoptic Technologies | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SUNOPTIC TECHNOLOGIES, LLC | 1 | 2022–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Sunoptic Technologies LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | BRANDCudaCustomer brandFIBEROPTIC HEADLIGHT SYSTEMSunoptics Surgical | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Sunoptic Technologies LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Cuda Products Co. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Jun 1989 | K893458 | FIBEROPTIC HEADLIGHT SYSTEM | Cuda Products Co. | EBA Surgical Headlight Light |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SUNOPTIC TECHNOLOGIES, LLCFDA reg. 1035968 | JACKSONVILLE, FL, United States | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1035968). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.