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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K251402
Device Name LIA-1 Catheter (542-1)
Applicant
Leadoptik, Inc.
2380 Qume Dr.
Suite A
San Jose,  CA  95131
Applicant Contact Mohammadreza Khorasaninejad
Correspondent
Qserve Group
350 S Main St., Suite 309
Doylestown,  PA  18901
Correspondent Contact Lorry Weaver
Regulation Number874.4680
Classification Product Code
KTI  
Date Received05/06/2025
Decision Date 12/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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