SOMNUM (SOMNUM)— 510(k) K253390

Substantially Equivalent

Honeynaps Co., Ltd.

FDA 510(k) clearance K253390 for SOMNUM (SOMNUM), Substantially Equivalent on 2026-06-27. Applicant: Honeynaps Co., Ltd.. Device class: 2.

Clearance details

Applicant: Honeynaps Co., Ltd.
Product code: Code OLZ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2025-09-30
Decision date: 2026-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLZ

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K250058 — NEAT 0012025-04-10
K241960 — DeepRESP2025-03-14

More clearances from Honeynaps Co., Ltd.

K223922 — SOMNUM (V.1.1.2.)2023-08-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.