Skytron, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

the 1140 Sentry, 2280 Syndicate, 3200 Max, and UV Smart D25 devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the devices as described and marketed.

Passage 2

The 1140 Sentry, 2280 Syndicate, 3200 Max, and UV Smart D25 devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81.

Passage 3

The UV Smart D25 device is further misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a) because of your misleading references, identified in the quoted statements below, to your firm’s registration. Your brochure for that device references that product’s FDA registration in the context of “use[] to clean non-invasive medical equipment,” which creates an impression of official FDA approval, clearance, authorization, or endorsement or other evaluation of your products that is misleading and constitutes misbranding.

Passage 4

the device is not exempt because it is not the type of device that is within the generic category of devices identified under § 880.6992. Generic devices of this type include functional steps that utilize mechanical processes to physically remove contamination from devices followed by a separate disinfection step, which can be either thermal or chemical. However, based on evidence obtained from your website, the UV Smart D25 is described as utilizing UVC to “clean non-invasive medical equipment.” However, we note that the device does not include a mechanical cleaning step, and disinfection is achieved utilizing non-ionizing UV-C radiation, with no mechanical action included.

Passage 5

Your materials continue to promote your devices for unapproved medical uses in violation of the Act after you responded to the IHCTOA letter and interactive e-mails indicating that you were going to remove the healthcare use claims for these devices from your webpage.