FDA Cleared

Serena Sleep FDA Cleared

In March 2021, the US Food and Drug Administration (FDA) cleared our Serena Sleep Solutions intraoral devices for both snoring and obstructive sleep apnea treatment. These devices are classified as Class II products under the Product Code LRK.

Serena Sleep’s 510K number K203606, covering the Serena Sleep Block Mandibular Advancement (Model name Elevate) and the Serena Sleep Elastic Mandibular Advancement (Model name Nylon ema).

At Serena Sleep, we are committed to providing our customers with safe and effective products for the treatment of snoring and obstructive sleep apnea.