Soft-Sert
Country not established
- Devices
- 1
What Soft-Sert makes
Soft-Sert manufactures single-use soft lens inserters, designed for precise placement of contact lenses during eye examinations or fittings. These devices are intended for clinical use in ophthalmic settings to streamline the lens application process.
The company’s portfolio is regulated under FDA Class I devices, with individual products authorised via 510(k) clearance. The inserters are listed in the FDA’s 510(k) database as medical devices. The manufacturer operates from the United States.
Catalogue
Soft Lens Inserter Ref K780931
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Soft-Sert have in the registry?
The registry currently lists 1 device for Soft-Sert. Devices recorded under merged duplicate company entries are counted once.
Which registries list Soft-Sert's devices?
Among its 1 most recently registered device, Soft-Sert has devices listed in FDA 510(k) (1 device).
What risk classes do Soft-Sert's devices fall under?
Among its 1 most recently registered device, the classes recorded for Soft-Sert's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Soft-Sert in the registry?
The most recently registered devices listed for Soft-Sert include SOFT LENS INSERTER.