Cerynë Intimate Care

Cerynë Intimate Care is a silicone-based personal lubricant for vaginal application intended to moisturize, lubricate, and enhance comfort during intimate sexual activity while supplementing the body's natural lubrication. It is compatible with natural rubber latex and polyisoprene condoms but not polyurethane condoms, and is sold over-the-counter in 15g and 30g tubes with a 2-year shelf life.

The subject device has a different formulation (silicone-based with multiple ingredients including dimethicone, cholesterol, and lactic acid) compared to the predicate's simpler cyclomethicone and dimethicone blend. Specifications differ in viscosity (25,000–45,000 cPs vs. 250–400 mPas), osmolality (250–300 mOsm/kg vs. not applicable), pH (3.5–4.5 vs. not applicable), and condom compatibility (incompatible with polyurethane vs. compatible). Microbial limits and other safety parameters are identical.

ISO 10993-5:2009/(R)2014 (cytotoxicity), ISO 10993-10:2021 (guinea pig sensitization), ISO 10993-23:2021 (vaginal irritation), ISO 10993-11:2017 (acute systemic toxicity), ASTM D7661-18 (condom compatibility), and USP standards for pH, viscosity, osmolality, and microbial limits.

The subject and predicate devices have similar indications for use and the same intended purpose of providing lubrication during intimate sexual activity. Although formulations and specifications differ, these differences do not raise new safety or effectiveness concerns. Biocompatibility testing demonstrates the device is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic, while condom compatibility testing confirms safe use with latex and polyisoprene condoms.