Eyemart Express, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Eyemart Express, Inc. makes
Eyemart Express, Inc. manufactures spectacle frames, which are designed for optical correction and eyewear fitting.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company operates within the United States.
Catalogue
Spectacle Frames Ref K941307
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Eyemart Express, Inc., initiated on 2014-09-12. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 12 Sep 2014 Z-0167-2015 Class II Terminated Prescription eyeglass safety lenses did not meet specifications.
Frequently asked questions
How many devices does Eyemart Express, Inc. have in the registry?
The registry currently lists 1 device for Eyemart Express, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eyemart Express, Inc.'s devices?
Among its 1 most recently registered device, Eyemart Express, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Eyemart Express, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Eyemart Express, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Eyemart Express, Inc.?
FDA recall records list 1 recall initiated by Eyemart Express, Inc., the most recent initiated on 2014-09-12. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Eyemart Express, Inc. in the registry?
The most recently registered devices listed for Eyemart Express, Inc. include SPECTACLE FRAMES.