Decision Date2025-12-19
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
LIA Console (542-7) is a medical device manufactured by Leadoptik, Inc.. It received FDA 510(k) clearance on 2025-12-19 under approval 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. It is manufactured by Leadoptik, Inc.. The 510(k) number is K251730.
When was LIA Console (542-7) approved by the FDA?
LIA Console (542-7) received FDA 510(k) clearance on 2025-12-19, under approval number K251730.
What company makes LIA Console (542-7)?
LIA Console (542-7) is manufactured by Leadoptik, Inc..
What is the FDA product code for LIA Console (542-7)?
The FDA product code for LIA Console (542-7) is NQQ.
Other Devices by Leadoptik, Inc.
Related Devices (Code: NQQ)
K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd.
K153283VivoSight Dx Topical OCT SystemMichelson Diagnostics, Ltd.
K160878OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc.
K160240Perimeter Otis 1.0 Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc.
K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation SystemNinepoint Medical, Inc.
K171560OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, 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.