510(k) Report

Devices descending from K043319

15 later devices reach Clareon and Solarus Pulsed Light Devices and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+1K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+1K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+2K083730IsolazAesthera Corporation20093—
+2K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+2K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+3K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+3K101415TheraclearTheravant Corporation20101—
+3K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+3K090399Trios SystemViora, Ltd.20090—
+4K123889Acleara, TheraclearTheravant Corporation20130—
+4K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+4K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+5K22079410PLTentech Co., Ltd.20220—
+5K181868SHINY RPL SystemIds, Ltd.20181—