Optikem International, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Optikem International, Inc. makes
Optikem International, Inc. manufactures contact lens storage cases and daily cleaners designed for silicone hydrogel (SIHy) soft contact lenses, including a hard contact lens case and an extra-strength cleaning solution.
These products are regulated as Class II and unclassified (U) devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Le Case Hard Contact Lens Storage Case Ref K822495
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optikem International, Inc. have in the registry?
The registry currently lists 2 devices for Optikem International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optikem International, Inc.'s devices?
Among its 2 most recently registered devices, Optikem International, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Optikem International, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Optikem International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optikem International, Inc. in the registry?
The most recently registered devices listed for Optikem International, Inc. include LE CASE HARD CONTACT LENS STORAGE CASE and SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES.