Illuminate

An examination lamp that only lights the field is not 'illuminating' in this sense. An active device that illuminates the patient's body in the visible spectrum as part of diagnosis falls under Rule 10 and is class IIa.

‘Illuminate’ means: to administer rays in visible light spectrum to for use in the process of diagnosis for example in visual electrophysiology and eye diseases, and not just to cast a light to improve the visibility. When performing diagnosis such as visual electrophysiology in search of eye diseases, the intended purpose of the device may not be limited to ‘illumination’.

MDCG 2021-24 Rev.1, Section 4.2, Rule 10, Practical issues of classification, Note 1