Contamac, Ltd. - FDA 510(k) Cleared Devices

Contamac, Ltd. is the world's largest manufacturer of contact and intraocular lens materials. The company develops specialist polymers and biocompatible materials for medical applications, with a manufacturing facility in Littleton, US. Contamac does not manufacture finished lenses; instead, it supplies raw materials to lens manufacturers globally.

Contamac has received 18 FDA 510(k) clearances from 18 total submissions since 2002. The company specializes exclusively in Ophthalmic devices, with its latest clearance in 2022. All submissions have been cleared, reflecting a strong regulatory track record in contact lens and intraocular lens materials.

The company's cleared devices include gas permeable contact lenses, silicone hydrogel materials, hydrophilic soft lens polymers, and intraocular lens materials. Notable product lines include the Optimum series (Infinite, Extreme, Extra, Comfort, and Classic), Contaflex soft lens materials, and hydrophilic IOL materials such as CI26 and CI25. Contamac operates an ISO 7 clean room and holds ISO 9001 and ISO 13485 accreditation.

Explore the full list of cleared device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Eyereg Consulting, Inc. as regulatory consultant.