Data / Medical devices / United States / Automated Ophthalmics Inc
Automated Ophthalmics Inc: FDA-registered device maker in Elkridge, MD, United States, 1 510(k) clearance
Automated Ophthalmics Inc is registered with the FDA (registration 3005906810) in Elkridge, MD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2000. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005906810
- Address
- 6671 Santa Barbara Rd Ste F, Elkridge, MD, United States, 21075
- Owner or operator
- Automated Ophthalmics Inc (10029051)
- Roles
- Manufacturer
- First device listed
- March 31, 2009
- Registered through
- 2027
- Brand names listed
- Optimal Tip Cover, Softips Tonopen Tipcover
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tonometer, Manual | HKY | 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 |
|---|---|---|---|---|---|---|
| January 10, 2000 | K992998 | AUTOMATED OPHTHALMICS SOFTIPS | HKY | Substantially Equivalent | Automated Ophthalmics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 10, 2000. 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.