Data / Medical devices / United States / Optos Inc.
Optos Inc.: FDA-registered device maker in Southborough, MA, United States, 8 510(k) clearances
Optos Inc. is registered with the FDA (registration 3005744933) in Southborough, MA, United States. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 9, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005744933
- Address
- 155 Northboro Rd Ste 12, Southborough, MA, United States, 01772
- Owner or operator
- OPTOS PLC (9035556)
- Roles
- Manufacturer
- First device listed
- December 19, 2006
- Registered through
- 2026
- Brand names listed
- 200Dx, 200Tx, California, Daytona, Monaco, Monaco Pro, Optos SPECTRAL OCT/SLO, P200 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ophthalmoscope, Ac-Powered | HLI | 2 | Manufacturer | accessdata.fda.gov |
| Ophthalmoscope, Laser, Scanning | MYC | 2 | Manufacturer | accessdata.fda.gov |
| Tomography, Optical Coherence | OBO | 2 | Manufacturer | 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 9, 2024 | K233602 | P200TE (A10700) | OBO | Substantially Equivalent | Optos Plc. | accessdata.fda.gov |
| August 18, 2023 | K231673 | P200TE (A10700) | OBO | Substantially Equivalent | Optos Plc. | accessdata.fda.gov |
| February 28, 2018 | K173707 | P200TE | OBO | Substantially Equivalent | Optos Plc. | accessdata.fda.gov |
| January 16, 2015 | K142897 | P200DTx | MYC | Substantially Equivalent | Optos Plc. | accessdata.fda.gov |
| August 19, 2011 | K111628 | P200T | MYC | Substantially Equivalent | Optos Plc. | accessdata.fda.gov |
| September 30, 2010 | K102492 | P200MAAF | MYC | Substantially Equivalent | Optos Plc. | accessdata.fda.gov |
| November 14, 2008 | K080460 | SPECTRAL OCT/SLO | OBO | Substantially Equivalent | Opko Health, Inc. | accessdata.fda.gov |
| February 3, 1999 | K983999 | PANORAMIC200 OPTHALMOSCOPE | HLI | Substantially Equivalent | Optos Plc. | accessdata.fda.gov |
Compare with other makers
- All makers of Ophthalmoscope, Laser, Scanning
- All makers of Tomography, Optical Coherence
- All makers of Ophthalmoscope, Ac-Powered
Updated May 9, 2024. 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.