Nuvolase Inc. – FDA Warning Letter, Sep 20, 2013

On May 8, 2014, the FDA issued a Warning Letter to Nuvolase, Inc. following an inspection from August 28 to September 20, 2013. The inspection revealed that Nuvolase's PinPointe Touch Screen Laser and PinPointe Foot Laser devices, intended for onychomycosis, were adulterated and misbranded.

The devices were found to be adulterated under section 501(f)(1)(B) of the Act because Nuvolase lacked an approved premarket approval (PMA) or investigational device exemption (IDE) application. They were also misbranded under section 502(o) for introducing devices into interstate commerce with major changes to intended use without submitting new premarket notification (510(k)).

Specifically, while cleared for "temporary increase of clear nail in patients with onychomycosis," Nuvolase promoted the devices for "treatment of onychomycosis," "destruction of fungus," and "effective in addressing nail infections" through labeling and website claims. These constitute major changes requiring new clearance or approval.

Furthermore, the devices were adulterated under Section 501(h) due to Quality System (QS) regulation violations (21 CFR Part 820). Violations included: 1. Failure to establish and maintain CAPA procedures, specifically not analyzing data from a regulatory consultant's notification about exceeding cleared indications