There are some odd red flags here. The Penuma website says:
Penuma® is the first FDA-cleared penile implant for cosmetic enhancement. Then it goes on to say that it is approved under the FDA 510(k) process. Problem: If your device is the first-of-a-kind, FDA requires you to seek approval under a different, more rigorous process known as PMA. To get 510(k), you need to name a "predicate device," that is, an existing, already-approved device to which yours is very similar. So, if you went the 510(k) route, you device can't be a first of its kind to be approved.
Second, FDA has no record of the name
Penuma, nor the company which owns this trademark,
Menova International. This alone is not necessarily a red flag, since devices are often advertised under trade names different from that under which they are registered. In this case, Penuma may refer to the whole procedure, not specifically the silicone sleeve itself. But there is some obfuscation here.
I suspect that the sleeve really is 510(k) approved, as there are many other prosthetic internal sleeve devices approved by FDA. But the First of its kind is probably misleading. I suspect that a surgeon took an existing silicone sleeve already approved for something else (erectile disfunction?), and did a clinical study to show it could be safely used for cosmetic purposes (enlargement). But there is a fine line here...
For example, Dr. Joel Kaplan sold well-known penis vacuum pumping cylinders, which he claimed were FDA approved. Yes and no...The cylinders were indeed FDA approved for the purpose of generating an erection in impotent men (approval # K974196), while they were advertised as being useful for penis enlargement, without mentioning that the FDA approval didn't cover this use. That earned Kaplan a nasty warning letter:
Dr. Joel Kaplan Inc. - 05/01/2014
Kaplan eventually resolved the problem by dropping the FDA-approved claim.
So, if anyone does contact Penuma to inquire about their procedure, as them for the K-number of the 510(k) approval. You can easily look this up on the FDA website, and find out exactly what the sleeve is, and what it was originally approved for.
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