I think I'm looking at something a little different,Kid...Maybe yours is newer. Did See this part...
After this advisory panel meeting, the FDA will consider all available scientific evidence and the input from panel members in determining whether to require PMA applications for nonthermal SWD devices or down-classify them into Class II or Class I. The FDA will then publish a proposed order announcing the agency’s intentions, which will be open for a public comment period. After consideration of all additional comments received, the FDA will intend to proceed with issuance of a final order to finalize the classification process for nonthermal SWD devices, which will identify the FDA’s final classification for this device type.