510(k) K242645

Device
INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
Applicant
Project Chemistry, Inc.
510(k) number
K242645
Product code
NUC
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-06
Date received
2024-09-03
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
No

Related Records

Applicant Contact

Contact
Jessica Graham
Address
18241 Gothard St. Huntington Beach CA US 92648 92648

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code NUC

510(k)DeviceApplicantDecision date
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
K251773Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)Shenzhen Yongquan Medical Devices Co., Ltd.2025-09-09
K250142Water-based LubricantGlobal Protection Corp.2025-08-08
K243972Plain Water-based LubricantGlobal Protection Corp.2025-08-08
K242712LubriZenzsSk Zen, LLC2025-06-04
K243107Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.2025-05-09
K250629Sutil Rich Personal LubricantHathor Professional Skincare , Ltd.2025-05-02
K242958Joylux Intimacy Gel (PG3100)Joylux, Inc.2025-03-20
K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)Hathor Professional Skincare , Ltd.2025-01-21