Are there any FDA-approved penis enlargement treatments?

1. FDA clearance vs. “approved” — an important regulatory distinction

Journalists and marketers sometimes conflate “FDA‑cleared” and “FDA‑approved.” Several sources state that the Penuma implant has 510(k) clearance for cosmetic enhancement of the flaccid penis — language used as regulatory clearance rather than full PMA approval — and describe it as the only penile enlargement surgery cleared for commercial use under the FDA’s 510(k) pathway ^{[1] [2] [3]}. Guidance documents on penile devices show the agency uses different pathways (510(k), PMA, guidance/exemptions) depending on device class and intended use ^{[8] [9]}.

2. Penuma: clearest example in peer‑review and consumer reporting

Peer‑reviewed commentary and mainstream health outlets identify Penuma as an FDA‑cleared aesthetic penile implant with multicenter data on patient satisfaction and described adverse events; clinical authors position it as the first device with that regulatory status for cosmetic flaccid enhancement ^{[1] [2]}. Consumer‑facing sites also note Penuma is cleared but not intended to treat erectile dysfunction and is usually not covered by insurance ^{[3] [10]}.

3. Other implants and clinics: competing claims and marketing language

Multiple clinics and commercial sites advertise other “FDA‑cleared” implants or the “world’s first FDA‑cleared” devices (for example, Himplant® and clinic pages claiming FDA clearance), but these are promotional pages rather than peer‑reviewed regulatory records in the provided results ^{[11] [12]}. Available sources do not provide independent FDA documentation for every device marketed this way; some marketing claims may overstate or simplify the regulatory picture (not found in current reporting).

4. Traction devices: some claims of FDA approval, but limited corroboration

A clinic blog asserts the Andro‑Extender is a US FDA‑approved penis traction device and quotes specific wear schedules and effect sizes ^[6]. That claim appears on a provider site; however, broader sources and older overviews have often said no FDA‑approved devices exist for penis extension ^[5]. The provided collection does not include an FDA record clearly corroborating the Andro‑Extender’s approval, so available sources do not conclusively confirm the device’s FDA status beyond the clinic’s assertion ^{[6] [5]}.

5. Injectables and “fillers”: FDA‑approved products vs. off‑label use

Several clinics advertise injectable fillers (hyaluronic acid dermal fillers) or branded “Magic Shot®” procedures as using “FDA‑approved” fillers for penile girth ^{[7] [13]}. Dermal fillers themselves may be FDA‑approved for facial soft‑tissue augmentation, but using them for penile augmentation can be an off‑label application; the provided sources note clinics’ claims but do not include FDA labeling decisions for penile use specifically ^{[7] [13]}. Some clinical-safety discussions caution that materials cleared for general surgical use are not necessarily approved for penile augmentation ^[14].

6. Medical societies, safety and realistic outcomes

Sources emphasize that many advertised pills and supplements lack FDA approval and evidence for size increase; clinicians and patient‑education sites warn that most non‑surgical methods don’t reliably work and can cause harm ^{[4] [5]}. Even for Penuma and other implants, reporting stresses limits: Penuma is cleared for cosmetic enhancement of the flaccid penis, may not increase erect length, is not an ED treatment, and carries surgical risks and typically out‑of‑pocket costs ^{[10] [3]}.

7. What this means for a consumer weighing options

If you seek an FDA‑cleared commercial option for cosmetic penile enlargement, the Penuma implant is the clearest, repeatedly cited example in peer‑reviewed and consumer reporting ^{[1] [2] [3]}. Other devices and services are marketed as “FDA‑cleared” or using “FDA‑approved” products, but available reporting here either stems from clinic marketing or is ambiguous about the agency’s exact finding ^{[11] [12] [6] [7]}. Non‑surgical pills lack FDA approval as enlargement treatments ^{[4] [5]}.

Limitations and next steps for verification: consult the FDA’s device database or 510(k)/PMA records to confirm current clearances for specific products (not found in current reporting), check peer‑reviewed outcome data beyond promotional sites, and get independent urologic consultation about risks, likely outcomes, and psychological screening for body‑image concerns (available sources do not mention specific FDA database entries here).