510(k) K253911

Derma-2 by Neko Health AB — Product Code LHQ

K253911 is an FDA 510(k) premarket notification submitted by Neko Health AB for the device "Derma-2". The FDA issued a decision of Substantially Equivalent on May 20, 2026. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980. Neko Health AB has at least 1 other 510(k) clearance on record.