Aqua Lube
FDA 510(k) K110325 · Mayer Laboratories, Inc.
510(k) numberK110325
Submission
- Device name
- Aqua Lube
- Applicant
- Mayer Laboratories, Inc.
Berkely, CA, US - Received
- February 3, 2011
- Decision date
- December 8, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUC – Lubricant, Personal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
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.
Other 510(k)s with product code NUC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based…NUC · Traditional | Maxigen Biotech, Inc. | 09/03/2026SE |
| K261905 | BUM OilNUC · Traditional | Bumlicious, LLC (DBA Bumlicious) | 08/07/2026SE |
| K261177 | PINKSLIP Water-Based Personal Lubricant and MoisturizerNUC · Traditional | Pinkslip, LLC | 07/09/2026SE |
| K261909 | Plum Vagiceuticals Vaginal Moisturizing SuppositoriesNUC · Traditional | PCCA, Inc. | 07/06/2026SE |
| K254011 | Flow Water-Based Personal LubricantNUC · Traditional | LBDO Group, Inc. | 06/22/2026SE |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)NUC · Traditional | PR Personal Care Laboratories | 06/11/2026SE |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)NUC · Traditional | Hathor Professional Skincare , Ltd. | 06/09/2026SE |
| K260068 | pjur NATURE Touch, 100 mlNUC · Traditional | Pjur Group Luxembourg S.A. | 05/21/2026SE |
| K254101 | Julva Velvé Water-Based Personal LubricantNUC · Traditional | Golden Isles Medical, Inc. | 04/16/2026SE |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…NUC · Traditional | Hudi Pharma Srl | 04/01/2026SE |
More from Hudi Pharma Srl
| 510(k) | Device | Decision |
|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male CondomMOL · Traditional | 03/30/2026SE |
| K130345 | Aqua Lube Natural Lubricant - Regular, WarmingNUC · Traditional | 08/01/2013SE |
| K113686 | Kimono Microthin with Aqua Lube, Reality Ultra LubricatedHIS · Abbreviated | 03/06/2012SE |
| K001974 | Ez-On CondomMOL · Traditional | 10/24/2001SE |
| K946374 | Kimono MicrothinHIS · Traditional | 11/08/1995SE |
| K946376 | MaxxHIS · Traditional | 09/22/1995SE |
| K943064 | Kimono (Condoms)HIS · Traditional | 09/22/1995SE |
| K925869 | Sheathes, Sterile SheathesITX · Traditional | 01/06/1994SE |
| K926049 | Digitex, Digitex HypoallergenicLYY · Traditional | 07/22/1993SE |
| K904375 | Kimono PlusHIS · Traditional | 11/26/1990SE |
Questions and answers
When was Aqua Lube cleared by the FDA?
Aqua Lube (K110325) received a 510(k) decision of Substantially Equivalent on December 8, 2011, 308 days after the submission was received.
What is the product code of K110325?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.