510(k) Report

Devices descending from K182453

2 later devices reach ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+2K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—