Data / Medical devices / Germany / Merz Aesthetics GMBH
Merz Aesthetics GMBH: FDA-registered device maker in Frankfurt Am Main Hesse, Germany, 3 PMA approvals
Merz Aesthetics GMBH is registered with the FDA (registration 3022121566) in Frankfurt Am Main Hesse, Germany. It lists 1 device type. The FDA files 3 PMA approvals under its listings, the newest dated July 9, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022121566
- Address
- Eckenheimer Landstrasse 100, Frankfurt Am Main Hesse, Germany, 60318
- Owner or operator
- Merz Aesthetics GmbH (10084473)
- Roles
- Exporter to the US
- First device listed
- February 25, 2022
- Registered through
- 2026
- Brand names listed
- Belotero Balance, Belotero Intense (+) Lidocaine, Belotero Volume (+) Lidocaine
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implant, Dermal, For Aesthetic Use | LMH | 3 | Exporter to the US | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 9, 2026 | P250016 | Belotero® Intense (+) Lidocaine | LMH | 4 | October 21, 2026 | accessdata.fda.gov |
| May 19, 2026 | P250020 | Belotero Volume (+) Lidocaine | LMH | 4 | September 10, 2026 | accessdata.fda.gov |
| November 14, 2011 | P090016 | BELOTERO BALANCE | LMH | 60 | May 3, 2026 | accessdata.fda.gov |
Compare with other makers
Updated October 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.