Data / Medical devices / United States / Surfacide, LLC.
Surfacide, LLC.: FDA-registered device maker in Waukesha, WI, United States, 1 510(k) clearance
Surfacide, LLC. is registered with the FDA (registration 3013869012) in Waukesha, WI, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 27, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013869012
- Address
- W229n1687 Westwood Dr Ste C, Waukesha, WI, United States, 53186
- Owner or operator
- Surfacide, LLC. (10095730)
- Roles
- Specification developer
- First device listed
- April 20, 2026
- Registered through
- 2027
- Brand names listed
- Helios+ UV-C System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Whole Room Microbial Reduction Device | QXJ | 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 |
|---|---|---|---|---|---|---|
| May 27, 2025 | K242604 | Helios+ UV-C System | QXJ | Substantially Equivalent | Preventamed Technologies, Inc. Dba Surfacide Manufacturing | accessdata.fda.gov |
Updated May 27, 2025. 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.