510(k) Report

Devices descending from K010618

10 later devices reach Palomar Dermalux Pulsed Light System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041554Aip Intense Pulsed Light SystemAesthera Corporation20059—
+2K062589Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd.20063—
+2K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+3K083730IsolazAesthera Corporation20093—
+3K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+3K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+3K071943Serenity Pro PSF SystemInolase 2002, Ltd.20071—
+4K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+4K101415TheraclearTheravant Corporation20101—
+5K123889Acleara, TheraclearTheravant Corporation20130—