
Acclarent, Inc.
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RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A is an FDA 510(k)-cleared medical device (K071845) manufactured by Acclarent, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 27, 2007. Regulation: 8.