Data / Medical devices / United States / S4optik LLC
S4optik LLC: FDA-registered device maker in Jacksonville, FL, United States, 7 510(k) clearances
S4optik LLC is registered with the FDA (registration 3004441848) in Jacksonville, FL, United States. It lists 24 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004441848
- Address
- 11825 Central Parkway, Jacksonville, FL, United States, 32224
- Owner or operator
- S4OPTIK LLC (9077083)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- September 2, 2005
- Registered through
- 2026
- Brand names listed
- Amoils Epithelial Scrubber, COBRA, CP-2033 CHART PROJECTOR, CROSS CYLINDER, FIXED PD TRIAL FRAME, Fundus Camera Kestrel 3100m; Fundus Camera RetiCam 3100, GOLDMANN APPLANATION TONOMETER - 870 TYPE, GOLDMANN APPLANATION TONOMETER - R900 TYPE 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 |
|---|---|---|---|---|---|---|
| September 1, 2023 | K221601 | MS-39 | OBO | Substantially Equivalent | C.S.O. S.R.L. | accessdata.fda.gov |
| January 22, 2020 | K190954 | Fundus Camera | HKI | Substantially Equivalent | Chongqing Bio Newvision Medical Equipment , Ltd. | accessdata.fda.gov |
| July 3, 2014 | K132987 | COBRA FUNDUS CAMERA | HKI | Substantially Equivalent | C.S.O. S.R.L. | accessdata.fda.gov |
| August 6, 2002 | K022054 | F 900 | HKY | Substantially Equivalent | C.S.O. S.R.L. | accessdata.fda.gov |
| June 6, 2000 | K992835 | C.S.O. TONOMETER | HKY | Substantially Equivalent | Cso | accessdata.fda.gov |
| November 9, 1999 | K992836 | SL990, SL980, SL950 | HJO | Substantially Equivalent | Cso | accessdata.fda.gov |
| January 9, 1997 | K962989 | AMOILS EPITHELIAL SCRUBBER | HOG | Substantially Equivalent | S. Percy Amoils | accessdata.fda.gov |
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Updated September 1, 2023. 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.