Lutech Industries

FDA Device Registration & Listing · Indianapolis, IN, US · Registration 3036423383

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
3036423383
FEI Number
3036423383
Entity Name
Lutech Industries
City/State/Country
Indianapolis, IN, US
Establishment Address
3910 Industrial Blvd, Indianapolis, IN 46254, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
Waverly Life Sciences LLC (Owner Number: 10092757)
Owner / Operator Contact Address
7515 Pelican Bay Blvd 10A, Naples, FL 34108, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K170446
PMA Number
N/A

All Registered Proprietary Names

LT-300 HD LT-300 SD

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HEX Colposcope (And Colpomicroscope) Obstetrics/Gynecology Class 2 884.1630 2025-02-14
HEX Colposcope (And Colpomicroscope) Obstetrics/Gynecology Class 2 884.1630 2025-02-14

Official Correspondent

Theodore Schenberg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Waverly Life Sciences LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036423383. Last updated year: 2026. Please use registration number 3036423383 when referencing this establishment in official correspondence.
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