NUC
- Product code
- NUC
- Device name
- Lubricant, Personal
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 31
- Summaries archived here
- 25 (direct download)
- 510(k) clearances (all years, FDA)
- 247 (all years; only the last 3 years are listed here)
FDA classification definition
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.
510(k) clearances, last 3 years (31)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261905 | 2026-08-07 | Bumlicious, LLC (DBA Bumlicious) | BUM Oil | |
| K261177 | 2026-07-09 | PINKSLIP, LLC | PINKSLIP Water-Based Personal Lubricant and Moisturi… | |
| K261909 | 2026-07-06 | PCCA, Inc. | Plum Vagiceuticals Vaginal Moisturizing Suppositori… | |
| K254011 | 2026-06-22 | LBDO Group, Inc. | Flow Water-Based Personal Lubricant | |
| K261292 | 2026-06-11 | PR Personal Care Laboratories | PR Water-Base Lube Personal Lubricant (PR Water-Base… | |
| K252914 | 2026-06-09 | Hathor Professional Skincare , Ltd. | Sutil Pure Personal Lubricant (models 1148, 1145, 11… | |
| K260068 | 2026-05-21 | Pjur Group Luxembourg S.A. | pjur NATURE Touch, 100 ml | FDA |
| K254101 | 2026-04-16 | Golden Isles Medical, Inc. | Julva Velvé Water-Based Personal Lubricant | |
| K260007 | 2026-04-01 | Hudi Pharma Srl | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyalu… | |
| K253983 | 2026-03-06 | Guangzhou Haoyimai Trading Co., Ltd. | Water-based lubricant | |
| K251011 | 2025-12-19 | Unipack, LLC | Chiavaye Personal Moisturizer | |
| K252935 | 2025-12-15 | Foshan Pingchuang Medical Technology C… | Hybrid personal lubricant (water&silicone) (5ml, 8ml… | — |
| K250488 | 2025-12-12 | Ansella Therapeutics | Cerynë Intimate Care | FDA |
| K251773 | 2025-09-09 | Shenzhen Yongquan Medical Devices Co.,… | Water-soluble Personal Lubricant (Satin Gel Vitamin … | |
| K250142 | 2025-08-08 | Global Protection Corp. | Water-based Lubricant | — |
| K243972 | 2025-08-08 | Global Protection Corp. | Plain Water-based Lubricant | — |
| K242712 | 2025-06-04 | Sk Zen, LLC | LubriZenzs | |
| K243107 | 2025-05-09 | Dongguan Yanxuan Biotechnology Co., Lt… | Water Solubility Human Body Lubricant | |
| K250629 | 2025-05-02 | Hathor Professional Skincare , Ltd. | Sutil Rich Personal Lubricant | |
| K242958 | 2025-03-20 | Joylux, Inc. | Joylux Intimacy Gel (PG3100) | |
| K241443 | 2025-01-21 | Hathor Professional Skincare , Ltd. | Sutil Luxe Personal Lubricant (models 1126, 0009, 00… | |
| K242645 | 2024-12-06 | Project Chemistry, Inc. | INA Moisturizing Intimate Lubricant Water-Based Pers… | |
| K240745 | 2024-09-27 | Westridge Laboratories, Inc. | ID Free Personal Lubricant | |
| K242162 | 2024-09-19 | Good Clean Love, Inc. | Coconut Hybrid | |
| K240081 | 2024-08-16 | Jiangxi Wulinxiang Biological Technolo… | Human Lubricant | |
| K234099 | 2024-06-07 | Select Labs, LLC | Select Hybrid Personal Lubricant, and Select Pure Si… | FDA |
| K232040 | 2024-03-01 | Tyros Biopharma, Inc. | Gynatrof | |
| K231794 | 2023-12-22 | Viramal Limited | Elegant Advanced CompHort | |
| K232093 | 2023-12-01 | Woo Essentials, Inc. | Woo More Play Coconut Love Oil | |
| K232091 | 2023-10-22 | CC Wellness, LLC | JO Coconut Hybrid Cooling Personal Lubricant | |
| K232090 | 2023-10-11 | CC Wellness, LLC | JO Coconut Hybrid Warming Personal Lubricant |
Official FDA classification page: NUC
Classification and pathway per current FDA publications. Data from openFDA (CC0).