Arc Devices Limited

Arc Devices Limited specializes in non-touch infrared thermometers, such as the ARC InstaTemp and ARC InstaTemp MD models. These devices measure body temperature without direct contact, making them useful for rapid readings in both medical and general settings. The focus is on convenience and hygiene by eliminating physical contact during temperature assessment.

Arc Devices Limited is based in the United States, which means its medical devices fall under FDA regulation. Since the company’s products are classified as Class II devices, they require 510(k) clearance—a premarket submission process—to demonstrate substantial equivalence to a legally marketed predicate device. This classification reflects moderate risk, necessitating formal regulatory review before commercialization.

Yes, Arc Devices Limited’s devices are listed in the FDA’s 510(k) database. This matters because inclusion in the 510(k) registry confirms that each device has undergone the required clearance process to ensure it meets FDA safety and effectiveness standards. For healthcare providers or buyers, this listing provides transparency and assurance that the devices comply with U.S. regulatory requirements before entering the market.

Arc Devices Limited’s devices are classified as FDA Class II. This classification indicates a moderate risk to the user, requiring special controls beyond general controls to ensure safety and performance. While Class II devices don’t pose the highest risk (like Class III), they still require formal regulatory pathways—such as the 510(k) clearance process—to verify their compliance with applicable regulations before they can be legally marketed in the U.S.