Does the FDA's medical-device clearance pathway (510(k)) apply to the NanoFlashing™ Medical vertical?
Last reviewed: .
Does the FDA's medical-device clearance pathway (510(k)) apply to the NanoFlashing™ Medical vertical?
The company publishes no FDA position, 510(k) or other, for the Medical vertical, and its Terms of Use describe that chapter as a Research Application.
The Terms of Use state: “As of the Effective Date, the Water, Textiles, Food packaging, and Medical devices chapters describe Research Applications. They do not describe finished products currently available from C-POLAR for those uses.” The Medical page states: “The NanoFlashing™ Medical Device has a permanent positive polarity, a fixed positive charge.” The company's two classification statements, under FIFRA in the United States and under Regulation (EU) No 528/2012, are written for the NanoFlashing™ Air Filter, a panel air filter for forced-air heating, ventilation and air-conditioning systems. The Terms of Use also state: “A test of a material, component, sample, or prototype does not establish the safety, efficacy, suitability, durability, compatibility, manufacturability, scalability, or performance of a finished product.”
Source: C-POLAR — Terms of Use, section 4, https://cpolar.tech/terms/; C-POLAR — NanoFlashing™ Medical, https://cpolar.tech/medical/; Statement of Classification for the NanoFlashing™ Air Filter, section 1.2, issued by NF Technical Products Inc.; Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 1.2, C-POLAR Technologies, Inc., 11 September 2026.
Reviewed on .
Sources
- C-POLAR — Terms of Use, section 4
- C-POLAR — NanoFlashing™ Medical
- Statement of Classification for the NanoFlashing™ Air Filter, section 1.2, issued by NF Technical Products Inc.
- Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 1.2, C-POLAR Technologies, Inc., 11 September 2026