Lifestyles Smooth 2-IN-1 Massage & Lubricant
FDA 510(k) K122476 · Ansell Healthcare Products, LLC
510(k) numberK122476
Submission
- Device name
- Lifestyles Smooth 2-IN-1 Massage & Lubricant
- Applicant
- Ansell Healthcare Products, LLC
San Luis Obispo, CA, US - Received
- August 14, 2012
- Decision date
- March 7, 2013
- 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 |
|---|---|---|
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis…KGO · Traditional | 08/23/2023SE |
| K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy DrugsKGO · Traditional | 05/26/2023SE |
| K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with…LZA · Traditional | 03/10/2022SE |
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with…LZA · Traditional | 06/13/2021SE |
| K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink…LZA · Traditional | 06/19/2020SE |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy…KGO · Traditional | 05/23/2019SE |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsKGO · Traditional | 03/22/2019SE |
| K171375 | Gammex PI Breach Detect Powder Free Surgical GloveKGO · Traditional | 02/06/2018SE |
| K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination GlovesLZA · Traditional | 12/29/2017SE |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - FlavoredMOL · Abbreviated | 08/02/2017SE |
Questions and answers
When was Lifestyles Smooth 2-IN-1 Massage & Lubricant cleared by the FDA?
Lifestyles Smooth 2-IN-1 Massage & Lubricant (K122476) received a 510(k) decision of Substantially Equivalent on March 7, 2013, 205 days after the submission was received.
What is the product code of K122476?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.