510(k) Report

Devices descending from K150883

9 later devices reach HyaloGYN Vaginal Hydrating Gel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211998Desnuda ReflectGood Clean Love, Inc.20216—
+1K200098VagiVital AktivgelPeptonic Medical AB20200—
+1K191052HyaloGYN Vaginal Moisturizing SuppositoriesFidia Farmaceutici S.P.A.20200—
+2K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC20260—
+2K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care Laboratories20260—
+2K254101Julva Velvé Water-Based Personal LubricantGolden Isles Medical, Inc.20260—
+2K250629Sutil Rich Personal LubricantHathor Professional Skincare, Ltd.20250—
+2K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla…Hathor Professional Skincare, Ltd.20251—
+3K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare, Ltd.20260—