510(k) Report

Devices descending from K914136

1,315 later devices reach Coherent Versapulse (TM) 2.1XE/2.1L Holmi Surg Lase through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+15K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+15K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+15K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+15K213889PicoStarAsclepion Laser Technologies GmbH20220—
+15K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+15K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+16K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—
+16K202503ChromeQuanta System Spa202012—
+17K253765Vanish ProDdc Technologies, Inc.20260—
+17K241527Pastelle ProWontech Co., Ltd.20253—
+17K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+17K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+17K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+18K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—