510(k) Report

Devices descending from K101098

17 later devices reach Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201612Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5Viramal Limited20211—
+1K203818Replens Long-Lasting Vaginal MoisturizerChurch & Dwight Co., Inc.20210—
+1K190752SatisfaiteFemmepharma Consumer Healthcare, LLC20191—
+1K152507Dr. Wolff Vagisan Moisturising CreamDr. August Wolff GmbH & Co. KG Arzeimittel20161—
+1K150883HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A.20159—
+2K231794Elegant™ Advanced CompHortViramal Limited20230—
+2K211998Desnuda ReflectGood Clean Love, Inc.20216—
+2K201922Trophikos Vaginal MoisturizerTrophikos, LLC20210—
+2K193444Vagisan MoistCream CremolumDr. August Wolff GmbH & Co. KG Arzneimittel20200—
+2K200098VagiVital AktivgelPeptonic Medical AB20200—
+2K191052HyaloGYN Vaginal Moisturizing SuppositoriesFidia Farmaceutici S.P.A.20200—
+3K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC20260—
+3K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care Laboratories20260—
+3K254101Julva Velvé Water-Based Personal LubricantGolden Isles Medical, Inc.20260—
+3K250629Sutil Rich Personal LubricantHathor Professional Skincare, Ltd.20250—
+3K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla…Hathor Professional Skincare, Ltd.20251—
+4K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare, Ltd.20260—