FDA.reportPublic FDA data

510(k) K251773

Device
Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)
Applicant
Shenzhen Yongquan Medical Devices Co., Ltd.
510(k) number
K251773
Product code
NUC
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-09
Date received
2025-06-10
Regulation
884.5300
Classification name
Lubricant, Personal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Pei Ye
Address
Rm. 309, Baiwangda Smart Park, Bantian, Longgang District Shenzhen CN 518100 518100

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NUC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.2026-09-03
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K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.2026-07-06
K254011Flow Water-Based Personal LubricantLBDO Group, Inc.2026-06-22
K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care Laboratories2026-06-11
K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.2026-06-09
K260068pjur NATURE Touch, 100 mlPjur Group Luxembourg S.A.2026-05-21
K254101Julva Velvé Water-Based Personal LubricantGolden Isles Medical, Inc.2026-04-16
K260007Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)Hudi Pharma Srl2026-04-01
K253983Water-based lubricantGuangzhou Haoyimai Trading Co., Ltd.2026-03-06
K251011Chiavaye Personal MoisturizerUnipack, LLC2025-12-19
K252935Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)Foshan Pingchuang Medical Technology Co., Ltd.2025-12-15
K250488Cerynë Intimate CareAnsella Therapeutics2025-12-12
K243972Plain Water-based LubricantGlobal Protection Corp.2025-08-08