Spectra-Scope Standalone System - Dermatological laser-induced breakdown spectroscopy system

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Speclipse Australia Pty Ltd

Class:

Class IIa

Manufactured by:

Speclipse Inc 4F 141 Unjung-ro Bundang-gu Seongnam-si, Gyeonggi-do Korea - Republic of

Therapeutic area:

63442 - Dermatological laser-induced breakdown spectroscopy system

Therapeutic indications:

Spectra-Scope? Standalone is an objective spectroscopic system designed as a tool to aid medical professionals in the assessment of suspicious skin lesions for skin cancers. Spectra-Scope? Standalone is not meant to be used to make a definitive diagnosis or to replace the expert opinion of a medical professional. It is intended to provide information that may be useful to the medical professionals in the biopsy decision. Spectra-Scope? Standalone is indicated for the evaluation of clinically suspicious lesions for skin cancers; basal cell carcinoma, squamous cell carcinoma, melanoma.

Authorization status:

A

Authorization date:

2020-04-03