DevicePMAs@therightstef:P040028_S000 JSONTXT

Approval for the luma cervical imaging system. The device is indicated for use as an adjunct to colposcopy for the identification of high-grade disease (cin 2, 3+) in women referred to colposcopy with a pap test result of atypical squamous cells (asc), low-grade squamous intraepithelial lesion (lsil) or high-grade squamous intraepithelial lesion or cancer (hsil+).