Data / Medical devices / United States / Sota Precision Optics, Inc.
Sota Precision Optics, Inc.: FDA-registered device maker in Orange, CA, United States, 5 510(k) clearances
Sota Precision Optics, Inc. is registered with the FDA (registration 3000190675) in Orange, CA, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 4, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3000190675
- Address
- 1073 N Batavia St Ste B, Orange, CA, United States, 92867
- Owner or operator
- SOTA PRECISION OPTICS, INC. (9057540)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 10, 2008
- Registered through
- 2027
- Brand names listed
- Claris i310, Claris i310D, Claris i5HD, Clio, Clio Pedo, Clio Prime, Cliosoft, SOTA Cloud and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Specification developer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| May 4, 2021 | K210682 | SOTA Cloud Imaging | LLZ | Substantially Equivalent | Sota Precision Optics, Inc. Dba Sota Imaging | accessdata.fda.gov |
| November 6, 2020 | K202664 | Clio Prime and Clio Pedo | MUH | Substantially Equivalent | Sota Precision Optics, Inc. Dba Sota Imaging | accessdata.fda.gov |
| June 30, 2011 | K110886 | CLIO/CLIOSOFT | LLZ | Substantially Equivalent | Sota Precision Optics, Inc. | accessdata.fda.gov |
| May 23, 2006 | K061175 | CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES | EIA | Substantially Equivalent | Sota Precision Optics, Inc. | accessdata.fda.gov |
| August 25, 2003 | K032341 | INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 | EIA | Substantially Equivalent | Sota Precision Optics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Unit, Operative Dental
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of Unit, Operative Dental, Accessories
Updated May 4, 2021. 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.