Cl-Tinters
Country not established
- Devices
- 3
What Cl-Tinters makes
Cl-Tinters manufactures hydrogel contact lenses designed for daily wear, including clear and tinted versions made from Polymacon material. These lenses are intended for prosthetic use, providing vision correction or cosmetic enhancement.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are registered in the United States.
Catalogue
Soft (Hydrophilic) Contact Lenses Ref K982774
Regimes: 510(k) Registry: 510(k)Prosthetic, Gelflex Alpha, (Polymacon) Hydrophilic Contact Lens For Daily Wear (Clear And Tinted) Ref K010126
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cl-Tinters have in the registry?
The registry currently lists 3 devices for Cl-Tinters. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cl-Tinters's devices?
Among its 3 most recently registered devices, Cl-Tinters has devices listed in FDA 510(k) (3 devices).
What risk classes do Cl-Tinters's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Cl-Tinters's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cl-Tinters in the registry?
The most recently registered devices listed for Cl-Tinters include SOFT (HYDROPHILIC) CONTACT LENSES, PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) and PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED).