In order for a personal lubricant to be sold and marketed in the United States, the FDA has started requiring all lubricants to have a Class II Medical Device 510(k) clearance. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalen, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to premarket approval. 510(k) clearance means that a company has done its due diligence with testing the product according to FDA guidelines and its been cleared for sale in the US.
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.
Regulation Medical Specialty
Office of Device Evaluation(ODE) Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD) Obstetrics and Gynecology Devices Branch (OGDB)
"By December 31, 2015, review 100 percent of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public."