FAQ (FAQ 411)— 510(k) K261565

Substantially Equivalent

Foreo, Inc.

FDA 510(k) clearance K261565 for FAQ (FAQ 411), Substantially Equivalent on 2026-10-22. Applicant: Foreo, Inc.. Device class: 2.

Clearance details

Applicant: Foreo, Inc.
Product code: Product code NFO
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2026-05-11
Decision date: 2026-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NFO

K261625 — FAQ (FAQ 401); FAQ (FAQ 402)2026-10-26
K261370 — LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))2026-09-16
K262861 — PureLift Pro Max2026-09-11
K260387 — SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)2026-08-31
K253932 — FACEGYM Pro Device (HD-109)2026-07-23

More clearances from Foreo, Inc.

K253683 — FAQ (LED Panel); FAQ (Dual LED Panel)2026-02-20
K242747 — FAQ (302)2024-12-11
K241102 — Luna 4 plus2024-08-20
K240616 — FAQ (102)2024-07-15
K232242 — BEAR 2 Body2024-05-13

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