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FDA 510(k)

Yomi Robotic System

K-Number: K251835 · 2025-10-10

ApplicantNeocis, Inc.
Decision Date2025-10-10
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Yomi Robotic System is a medical device manufactured by Neocis, Inc.. It received FDA 510(k) clearance on 2025-10-10 under approval number K251835. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Yomi Robotic System?

Yomi Robotic System is a medical device that received FDA 510(k) clearance on 2025-10-10. It is manufactured by Neocis, Inc.. The 510(k) number is K251835.

When was Yomi Robotic System approved by the FDA?

Yomi Robotic System received FDA 510(k) clearance on 2025-10-10, under approval number K251835.

What company makes Yomi Robotic System?

Yomi Robotic System is manufactured by Neocis, Inc..

What is the FDA product code for Yomi Robotic System?

The FDA product code for Yomi Robotic System is PLV.

Related Clinical Trials

NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING NCT07606963 Triton 1.5 Robotic System for Diagnostic Colonoscopy NOT_YET_RECRUITING NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT07524699 A Study About Remote and Local Liver Surgery NOT_YET_RECRUITING NCT07566767 Effect of Robotic Gait on Functions in Cerebral Palsy COMPLETED

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Neocis, Inc.

K161399Neocis Guidance System K182776Neocis Guidance System K173402Neocis Guidance System (NGS) with Chairside Splint K191363Neocis Planning Software Application (NPSA) for 3rd Party PCs K191605Neocis Guidance System (NGS) K203401Neocis Guidance System (NGS) with Patient Splints (EPS)

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Related Devices (Code: PLV)

K161399Neocis Guidance SystemNeocis, Inc. K161406NavidentClaronav, Inc. K182776Neocis Guidance SystemNeocis, Inc. K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsNeocis, Inc. K191605Neocis Guidance System (NGS)Neocis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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