Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LIA Console (542-7)

K-Number: K251730 · 2025-12-19

ApplicantLeadoptik, Inc.
Decision Date2025-12-19
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LIA Console (542-7) is the device name listed in this FDA 510(k) record. The listed applicant is Leadoptik, Inc.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K251730. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIA Console (542-7)?

LIA Console (542-7) is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Leadoptik, Inc.. The 510(k) number is K251730.

When did LIA Console (542-7) receive FDA 510(k) clearance?

LIA Console (542-7) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K251730.

Who is the listed applicant for LIA Console (542-7)?

The FDA 510(k) record lists Leadoptik, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIA Console (542-7)?

The FDA product code for LIA Console (542-7) is NQQ.

Other records listing Leadoptik, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251402LIA-1 Catheter (542-1)

Related Devices (Code: NQQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICALK253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.K252851deepLive (OSP12 + DMS)Damae MedicalK251198HyperVue™ SoftwareSpectrawave, Inc.K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi PlantK242924OPXION Optical Skin Viewer (OPXSV1-01F)Opxion Technology, 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.

↑