510(k) Report

Devices descending from K052643

16 later devices reach Epiceram through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252568New Day Skin SpraySilk Holdings, Inc.20260—
+1K242406SiOxC CreamSioxmed, LLC20251—
+1K171191Hexagen DermGlobal Health Solutions, LLC20170—
+1K152055Ceramax Skin Barrier CreamOculus Innovative Sciences201501
+1K113807Dexeryl CreamPierre Fabre Medical Devices20120—
+1K110757TL-Cermide Skin Barrier EmulsionTrigen Laboratories, Inc.20111—
+1K110732Emulsion SBPrugen IP Holdings, Inc.20110—
+1K093051Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated20096—
+1K080471Radio BioaquacareBioartificial Gel Technologies (Bagtech), Inc.20080—
+2K250890SBC1 CreamSioxmed, LLC20260—
+2K113774HPR Plus Emollient FoamPrugen IP Holdings, Inc.20121—
+2K110727Hylatopicplus CreamPrecision Dermatology Incorporated20114—
+3K150914Dash-Topic Plus CreamFounders Science Group, LLC20160—
+3K132329Nivatopic PlusNivagen Pharmaceuticals, Inc.20130—
+3K123678Hyalmix CreamIgi Laboratories, Inc.20130—
+3K121559Hylatopicplus LotionPrecision Dermatology Incorporated20120—