MEDTRONIC, INC. AFR-00007 null

RhodoLED® XL is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.

Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner. It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.

Accessory device of the ClearCorrect System clear aligner system. Device is used by the clinician to add composite features to the teeth, referred to as Engagers. The Engagers have orthodontic force applied to them by the Aligners of the ClearCorrect System. The use of Engagers facilitates Aligner retention on the teeth and also facilities certain tooth movements that are difficult to achieve by applying force to the tooth surface itself. The Engager Template is used by the clinician in the clinical setting. The device is single use and disposed of after use. Duration of use is less than one hour.