illuminating device/ light delivery systems (photodynamic therapy)

Outcome Measure

a. Efficacy: Mortality, morbidity (symptom burden, symptom improvement, time to healing), quality of life (patient-based outcomes, such as cosmetic appearance, QoL or depression scores), resource use (e.g. length of hospital stay), return to normal activities, recurrence and tumour response measures<br>b. Safety: Adverse events (ulceration of the underlying tissues, haemoptysis, scarring, carcinogenicity, oesophageal strictures, cardiac complications, nausea, inflammation, pain, constipation) (p. 8)

Body Classification

Lungs and Breathing; Brain and Nerves; Digestive System; Skin, Hair and Nails

Device Type

Diagnostic device

Device Category

Treatment of disease

Risk Classification



precancerous skin conditions, Barrett’s oesophagus and cancers of the biliary tract, brain, head and neck, lung, oesophagus and skin