Ambicare has successfully achieved regulatory approvals in Europe for its non melanoma skin cancer and acne products in early 2012. Ambicare is now expanding to support commercialisation and hope to achieve a 510k for its acne product (Lustre Pure Light) this year.
The company's first medical product, Ambulight Multi PDT, is a disposable ambulatory light source for the PDT treatment of non-melanoma skin cancers. Simple and easily applied it offers significant benefits to patients, medical professionals and healthcare providers.
PDT is as a well established alternative to surgery for many forms of skin cancer.
In addition to medical devices, Ambicare is developing consumer healthcare phototherapy products. Applications include acne and skin rejuvenation.
The Lustre Pure Light device, developed for the treatment of spots and acne, is a small, rechargeable product with slim, flexible therapy heads which target problem areas.
Lustre Pure Light delivers safe, visible blue light at a wavelength of 420nm; this has been clinically proven to eliminate P. Acnes through porphyrin oxidisation.
Ambicare is an ISO 13485:2003 certified company.
This certification demonstrates the company has a quality management system that is able to provide medical devices and related services that consistently meet customer and regulatory requirements.