Data / Medical devices / United States / Lipocosm, LLC
Lipocosm, LLC: FDA-registered device maker in Key Biscayne, FL, United States, 1 510(k) clearance
Lipocosm, LLC is registered with the FDA (registration 3008023310) in Key Biscayne, FL, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 8, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008023310
- Address
- 580 Crandon Blvd Ste 201, Key Biscayne, FL, United States, 33149
- Owner or operator
- Lipocosm, LLC (10034847)
- Roles
- Specification developer
- First device listed
- February 8, 2017
- Registered through
- 2026
- Brand names listed
- Approximator, HarmonicLipo, KNeedle, Pexybra
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Binder, Breast | HEF | 1 | Specification developer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Specification developer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Specification developer | accessdata.fda.gov |
| System, Suction, Lipoplasty For Removal | QPB | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 8, 2026 | K251944 | Lipocosm Harmonic System | QPB | Substantially Equivalent | Lipocosm, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Forceps, General & Plastic Surgery
- All makers of Dissector, Surgical, General & Plastic Surgery
- All makers of System, Suction, Lipoplasty For Removal
- All makers of Binder, Breast
Updated June 8, 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.