Data / Medical devices / United States / Benev Company Inc
Benev Company Inc: FDA-registered device maker in Mission Viejo, CA, United States, 4 510(k) clearances
Benev Company Inc is registered with the FDA (registration 3003205477) in Mission Viejo, CA, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003205477
- Address
- 23263 Madero Ste A, Mission Viejo, CA, United States, 92691
- Owner or operator
- BENEV Company Inc (10096172)
- Roles
- Complaint file establishment
- First device listed
- October 20, 2026
- Registered through
- 2026
- Brand names listed
- CODE-X, SMARTLUX MINI, SYLFIRM, XTHERMA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 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 |
|---|---|---|---|---|---|---|
| May 13, 2026 | K252591 | Automatic Micro Needle System (CODE-X) | QAI | Substantially Equivalent | Woorhi Mechatronics Co., Ltd. | accessdata.fda.gov |
| December 20, 2023 | K232992 | 10THERMA | GEI | Substantially Equivalent | Tentech, Inc. | accessdata.fda.gov |
| July 12, 2022 | K221083 | Smartlux Mini | GEX | Substantially Equivalent | Medmix Co., Ltd. | accessdata.fda.gov |
| June 23, 2022 | K213612 | SYLFIRM X | GEI | Substantially Equivalent | VIOL Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Powered Laser Surgical Instrument
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Powered Microneedle Device
Updated May 13, 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.