510(k) Report

Devices descending from K041342

44 later devices reach Impruv a.I. Cream Wound and Skin Emulsion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171879HylaGuard Moisturizing CreamFounders Science Group, LLC20170—
+1K152533Xonrid GelHelsinn Healthcare SA20160—
+1K141637SPB Skin EmulsionBiotd S.A.20150—
+1K140905DermafineInvado Pharmaceuticals20150—
+1K130781L.a.M. Ipm Wound Gel, Ipm Derm GelGlycobiosciences, Inc.20141—
+1K110172Sonafine Wound DressingStratus Pharmaceutical20112—
+1K093544Tropazone CRMidlothian Laboratories20101—
+1K093051Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated20096—
+1K092297Eletone CreamFerndale Pharma Group, Inc.20090—
+1K090337Tropazone LotionMidlothian Laboratories20093—
+1K083024Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated20098—
+1K082089Prumyx CreamPrugen, Inc.20093—
+1K070309NeosalusQuinnova Pharmaceuticals20085—
+1K073246ZenievaGorbec Pharmaceutical Services, Inc.20087—
+1K071483Tetrix CreamCoria Laboratories, Ltd.20082—
+1K060272Locobase Wound and Skin EmulsionFerndale Laboratories, Inc.200710—
+1K052643EpiceramCeragenix Corporation200616—
+2K252568New Day Skin SpraySilk Holdings, Inc.20260—
+2K242406SiOxC CreamSioxmed, LLC20251—
+2K233151PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)Medline Industries, LP20240—
+2K171191Hexagen DermGlobal Health Solutions, LLC20170—
+2K162217LOYONOculus Innovative Sciences20170—
+2K152055Ceramax Skin Barrier CreamOculus Innovative Sciences201501
+2K143527IPM Wound Gel Bio, IPM Derm Gel BioGlycobiosciences, Inc.20150—
+2K113807Dexeryl CreamPierre Fabre Medical Devices20120—
+2K113772HPR Emollient FoamPrugen IP Holdings, Inc.20120—
+2K113774HPR Plus Emollient FoamPrugen IP Holdings, Inc.20121—
+2K110757TL-Cermide Skin Barrier EmulsionTrigen Laboratories, Inc.20111—
+2K110732Emulsion SBPrugen IP Holdings, Inc.20110—
+2K110727Hylatopicplus CreamPrecision Dermatology Incorporated20114—
+2K093159PR CreamPrugen IP Holdings, Inc.20100—
+2K090585Neosalus CreamQuinnova Pharmaceuticals20094—
+2K082865Modification to ZenievaGorbec Pharmaceutical Services, Inc.20082—
+2K080471Radio BioaquacareBioartificial Gel Technologies (Bagtech), Inc.20080—
+3K250890SBC1 CreamSioxmed, LLC20260—
+3K240722Derma-R Cream (Derma-R Cream)Raya Pharmaceuticals, LLC20240—
+3K170911NEOCERA Advanced Barrier CreamExeltis USA Dermatology, LLC20170—
+3K150914Dash-Topic Plus CreamFounders Science Group, LLC20160—
+3K132329Nivatopic PlusNivagen Pharmaceuticals, Inc.20130—
+3K123678Hyalmix CreamIgi Laboratories, Inc.20130—
+3K121559Hylatopicplus LotionPrecision Dermatology Incorporated20120—
+3K091719Neosalus LotionQuinnova Pharmaceuticals20090—
+3K083721Modification to ZenievaRiver'S Edge Pharmaceuticals, LLC20091—
+4K100839BarirepGorbec Pharmaceutical Services, Inc.20100—