510(k) Report

Devices descending from K094039

19 later devices reach Hyalo Gyn through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193448BioNourish LubricantGood Clean Love, Inc.20200—
+1K153372Repagyn vaginal suppositoriesFarma-Derma S.R.L.20164—
+1K150883HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A.20159—
+1K141718Internal Hydrating GelCombe Incorporated20142—
+2K213220Revaree Plus Vaginal SuppositoriesFarma-Derma S.R.L.20223—
+2K211998Desnuda ReflectGood Clean Love, Inc.20216—
+2K200098VagiVital AktivgelPeptonic Medical AB20200—
+2K191052HyaloGYN Vaginal Moisturizing SuppositoriesFidia Farmaceutici S.P.A.20200—
+2K171855External Moisturizing GelCombe Incorporated20170—
+2K150615Vaginal Moisturizing GelCombe Incorporated20151—
+3K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC20260—
+3K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.20260—
+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—
+3K260007Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…Hudi Pharma Srl20260—
+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—
+3K230518HydraDose Vaginal SuppositoriesMD Labs, LLC20230—
+4K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare, Ltd.20260—