LEADOPTIK INC.

FDA Device Registration & Listing · San Jose, CA, US · Registration 3042970803

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042970803
FEI Number
3042970803
Entity Name
LEADOPTIK INC.
City/State/Country
San Jose, CA, US
Establishment Address
2380 Qume Dr Ste A, San Jose, CA 95131, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Leadoptik Inc. (Owner Number: 10094418)
Owner / Operator Contact Address
2380 Qume Dr, Suite A, San Jose, CA 95131, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251402
PMA Number
N/A

All Registered Proprietary Names

LIA Console LIA-1 Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2026-01-07
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2026-01-07

Official Correspondent

Mohammadreza Khorasaninejad

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Leadoptik Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K183320 St. Jude Medical (Now Abbott Medical) Ilumien Optis, Optis Integrated, Optis Mobile 2019-04-02
K253459 ABBOTT MEDICAL OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) 2026-04-24
K210458 ABBOTT MEDICAL OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System 2021-06-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042970803. Last updated year: 2026. Please use registration number 3042970803 when referencing this establishment in official correspondence.
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