Getting Your FDA 510(k) Medical Device Approved: How Long Does It Take?

How long does it take to get FDA approval for your medical device? About 90 days according to Palomar's CFO Paul Weiner.

Since we posted about Fairwarning's article on the RevecoMED LipoTron (or Lipo-Ex) there has been a lot of fiery back-and-forth in the comments and we've been getting more than the usual number of emails, including emails asking us questons about FDA approvals of medical devices in the US.

Read Fairwarning: The LipoTron 3000 (Lipo-Ex) FDA UnApproved $85k Massager

Now I have no real experience with any of the individuals or companies involved but one of the comments from the Fairwarning article caught my attention. It was this:

The company’s (RevecoMED's) initial application “wasn’t in-depth enough,” Rosen said, and the FDA repeatedly sought additional data. Finally, according to Rosen, “We said, ‘You know what, it’s not worth it.”

"It's not worth it"?

I would have thought that any business producing and selling cosmetic medical devices in the US would view FDA approval as being absolutely mandatory.

Perhaps the LipoTron guys know something I don't.

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