Yomi Robotic System— 510(k) K222750

Substantially Equivalent

Neocis, Inc.

FDA 510(k) clearance K222750 for Yomi Robotic System, Substantially Equivalent on 2022-12-08. Applicant: Neocis, Inc.. Device class: 2.

Clearance details

Applicant: Neocis, Inc.
Product code: Code QRY
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2022-09-12
Decision date: 2022-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QRY

K253954 — X-Guide Surgical Navigation System2026-08-28
K232148 — X-Guide Surgical Navigation System2024-02-21
K222049 — Yomi Robotic System2022-11-04
K211701 — X-Guide® Surgical Navigation System2022-02-01

More clearances from Neocis, Inc.

K252376 — Yomi S Robotic System2025-10-28
K251835 — Yomi Robotic System2025-10-10
K231018 — Yomi Robotic System2023-08-14
K211466 — Yomi Robotic System with YomiPlan Go2022-06-14
K210711 — Neocis Guidance System (NGS) with Yomi Plan v2.0.12021-12-22

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