510(k) K253911 ยท LHQ System, Telethermographic (Adjunctive Use)
Derma-2
| Applicant | Neko Health AB, Danderyd, SE |
| Decision | Substantially Equivalent, May 20, 2026 |
| Received | Dec 8, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253911
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.