Can a diagnostic device be class I?

[Daliane]

Hi all,
I am supporting startup companys with classification strategys by comparing other companys with similar products.
Can someone help to understand or interpret how this company has classified a non-invasive image device for skin tumor diagnostic as class I?

Background about the product: non-invasive image diagnostic device (still no market access - in clinical investigation stage)
Its intended use is:
• real-time diagnosis for all skin tumors
• Definition of accurate pre-surgical margins for skin surgery
• Guiding therapy to enable less invasive therapies, follow up treatment response and to select the best treatment/dosage

Device:
It consists of three pieces, a microscope like devices for scanning, the monitor to view the images, the optics (laser) which is a combination of Linear Confocal Microscopy and Optical Coherence Tomography.

According to the MDD, Rule 10:
Active Devices intended for diagnosis are in class IIa:
— if they are intended to supply energy which will be absorbed by the human body, except for devices used to illuminate the patient's body, in the visible spectrum,

Can you please help to understand why this device is a class I? According to my interpretation it is class IIa.
A brochure if you need: https://damae-medical.com/files/Brochure_deepLive.pdf

Thank you!
Any feedback much appreciated

Regards
Daliane

 

[Mikilk]

in the brochure that you provided, it seems that it is only illuminating - or imaging the skin condition - nothing here said that it is a diagnostic device

Active devices intended for diagnosis and monitoring are classified as class IIa: — if they are intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I;

I'm not familiar with the device and it is not my professional consultation, I only raised a point