Data / Medical devices / United States / Bellus Medical, LLC
Bellus Medical, LLC: FDA-registered device maker in Johnson City, TN, United States, 5 510(k) clearances
Bellus Medical, LLC is registered with the FDA (registration 3010392991) in Johnson City, TN, United States. It lists 8 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 29, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010392991
- Address
- 207 Mockingbird Ln, Johnson City, TN, United States, 37604
- Owner or operator
- Bellus Medical, LLC (10044925)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- December 11, 2015
- Registered through
- 2027
- Brand names listed
- 18G X 1" Venting Needle; 30G X 1/2" Hypodermic Needle, BTR PRP, Boost 2+ Flex, DermaFlex Aspiration Needle, DermaFlex MicroCannula, EVO Decontaminator, Genesis PRP, Gold Rush PRP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Disinfector, Medical Devices | MEC | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Powered Microneedle Device | QAI | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 29, 2024 | K241400 | SkinPen Precision Elite System | QAI | Substantially Equivalent | Crown Aesthetics | accessdata.fda.gov |
| November 24, 2021 | K212558 | MicroPen EVO | QAI | Substantially Equivalent | Eclipse Medcorp, LLC | accessdata.fda.gov |
| November 5, 2020 | K200017 | Eclipse DermaFlex Cannula | FMI | Substantially Equivalent | Eclipse Medcorp, LLC | accessdata.fda.gov |
| June 14, 2018 | K172938 | Disposable Sterile Needle | FMI | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| March 1, 2018 | DEN160029 | SkinPen Precision System | QAI | Unknown | Bellus Medical, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 18, 2019 | 84154 | Class II | Terminated | SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used to soothe and calm skin (cosmetic). The SKINFUSE LIFT HG is a hydrogel wound dres | Cosmetic Kit was packaged with a mislabel medical product. | accessdata.fda.gov |
Compare with other makers
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
- All makers of Disinfector, Medical Devices
- All makers of Powered Microneedle Device
- All makers of Platelet And Plasma Separator For Bone Graft Handling
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Updated August 29, 2024. 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.