FDA Product Code NUC: Lubricant, Personal
This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms.
Leading manufacturers include CC Wellness, LLC, United Consortium and Rb Health (Us), LLC.
246
Total
246
Cleared
185d
Avg days
2000
Since
Stable submission activity - 24 submissions in the last 2 years
Review times improving: avg
156d
recently vs 189d historically
FDA 510(k) Cleared Lubricant, Personal Devices (Product Code NUC)
246 devices
Cleared
May 21, 2026
pjur NATURE Touch, 100 ml
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology
132d
Cleared
Apr 16, 2026
Julva Velvé Water-Based Personal Lubricant
Golden Isles Medical, Inc.
Obstetrics & Gynecology
118d
Cleared
Apr 01, 2026
Hyaluronic Acid Vaginal Suppository (HA 5 mg)
Hudi Pharma Srl
Obstetrics & Gynecology
89d
Cleared
Mar 06, 2026
Water-based lubricant
Guangzhou Haoyimai Trading Co., Ltd.
Obstetrics & Gynecology
84d
Cleared
Dec 19, 2025
Chiavaye Personal Moisturizer
Unipack, LLC
Obstetrics & Gynecology
262d
Cleared
Dec 15, 2025
Hybrid 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.
Obstetrics & Gynecology
91d
Cleared
Dec 12, 2025
Cerynë Intimate Care
Ansella Therapeutics
Obstetrics & Gynecology
296d
Cleared
Sep 09, 2025
Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant
Shenzhen Yongquan Medical Devices Co., Ltd.
Obstetrics & Gynecology
91d
Cleared
Aug 08, 2025
Plain Water-based Lubricant
Global Protection Corp.
Obstetrics & Gynecology
228d
Cleared
Aug 08, 2025
Water-based Lubricant
Global Protection Corp.
Obstetrics & Gynecology
203d
Cleared
Jun 04, 2025
LubriZenzs
Sk Zen, LLC
Obstetrics & Gynecology
268d
Cleared
May 09, 2025
Water Solubility Human Body Lubricant
Dongguan Yanxuan Biotechnology Co., Ltd.
Obstetrics & Gynecology
221d
Cleared
May 02, 2025
Sutil Rich Personal Lubricant
Hathor Professional Skincare , Ltd.
Obstetrics & Gynecology
60d
Cleared
Mar 20, 2025
Joylux Intimacy Gel (PG3100)
Joylux, Inc.
Obstetrics & Gynecology
176d
Cleared
Jan 21, 2025
Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011)
Hathor Professional Skincare , Ltd.
Obstetrics & Gynecology
244d
Cleared
Dec 06, 2024
INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
Project Chemistry, Inc.
Obstetrics & Gynecology
94d
Cleared
Sep 27, 2024
ID Free Personal Lubricant
Westridge Laboratories, Inc.
Obstetrics & Gynecology
192d
Cleared
Sep 19, 2024
Coconut Hybrid
Good Clean Love, Inc.
Obstetrics & Gynecology
57d
Cleared
Aug 16, 2024
Human Lubricant
Jiangxi Wulinxiang Biological Technology Co., Ltd.
Obstetrics & Gynecology
218d
Cleared
Jun 07, 2024
Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant
Select Labs, LLC
Obstetrics & Gynecology
164d
Cleared
Mar 01, 2024
Gynatrof
Tyros Biopharma, Inc.
Obstetrics & Gynecology
235d
Cleared
Dec 22, 2023
Elegant™ Advanced CompHort
Viramal Limited
Obstetrics & Gynecology
185d
Cleared
Dec 01, 2023
Woo More Play Coconut Love Oil
Woo Essentials, Inc.
Obstetrics & Gynecology
141d
Cleared
Oct 22, 2023
JO Coconut Hybrid Cooling Personal Lubricant
CC Wellness, LLC
Obstetrics & Gynecology
101d
About Product Code NUC - Regulatory Context
510(k) Submission Activity
246 total 510(k) submissions under product code NUC since 2000, with 246 receiving FDA clearance (average review time: 185 days).
Submission volume has remained relatively stable over the observed period, with 24 submissions in the last 24 months.
FDA 510(k) Review Time - NUC Product Code
Recent submissions under NUC have taken an average of 156 days to reach a decision - down from 189 days historically, suggesting improved FDA processing for this classification.
NUC devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →