LIA Console (542-7)
FDA 510(k) K251730 · Leadoptik, Inc.
510(k) numberK251730
Submission
- Device name
- LIA Console (542-7)
- Applicant
- Leadoptik, Inc.
San Jose, CA, US - Received
- June 6, 2025
- Decision date
- December 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQQ – System, Imaging, Optical Coherence Tomography (Oct)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1560
- Specialty
- Radiology
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
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| K243016 | Starlight Imaging CatheterNQQ · Special | Spectrawave, Inc. | 03/20/2025SE |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30…NQQ · Special | Gentuity, LLC | 08/16/2024SE |
| K240610 | deepLiveNQQ · Traditional | Damae Medical | 07/09/2024SE |
More from Damae Medical
| 510(k) | Device | Decision |
|---|---|---|
| K251402 | LIA-1 Catheter (542-1)KTI · Traditional | 12/19/2025SE |
Questions and answers
When was LIA Console (542-7) cleared by the FDA?
LIA Console (542-7) (K251730) received a 510(k) decision of Substantially Equivalent on December 19, 2025, 196 days after the submission was received.
What is the product code of K251730?
The FDA product code is NQQ – System, Imaging, Optical Coherence Tomography (Oct), a Class II (moderate risk) device regulated under 21 CFR 892.1560.