Data / Medical devices / United States / Neoconcepts LLC
Neoconcepts LLC: FDA-registered device maker in Lewis Center, OH, United States, 3 510(k) clearances
Neoconcepts LLC is registered with the FDA (registration 3015227849) in Lewis Center, OH, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015227849
- Address
- 2773 Alum Crossing Dr., Lewis Center, OH, United States, 43035
- Owner or operator
- NEOconcepts LLC (10085708)
- Roles
- Complaint file establishment
- First device listed
- August 12, 2026
- Registered through
- 2026
- Brand names listed
- AgeJet, Exceed Unlimited, Prism Plasma
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment | accessdata.fda.gov |
| Low Power Electrosurgical Devices For Skin Lesion Destruction | QVJ | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Microneedle Device | QAI | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| February 23, 2024 | K233709 | Exceed Unlimited | QAI | Substantially Equivalent | Mt. Derm GmbH | accessdata.fda.gov |
| February 20, 2024 | K233760 | Mjolnir Pro. (Multielectrode plasma) | QVJ | Substantially Equivalent | Shenzhen Leaflife Technology Co., Ltd. | accessdata.fda.gov |
| July 7, 2022 | K212472 | AgeJet | GEI | Substantially Equivalent | Triworks Group Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Microneedle Device
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Low Power Electrosurgical Devices For Skin Lesion Destruction
Updated February 23, 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.