Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017978518

FEI Number

3017978518

Entity Name

TEARRESTORE INC

City/State/Country

Arden Hills, MN, US

Establishment Address

4440 Round Lake Rd W, Arden Hills, MN 55112, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

TearRestore Inc (Owner Number: 10080299)

Owner / Operator Contact Address

1507 Sherman Lake Road, Lino Lakes, MN 55038, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TearRestore EyeRelax TearRestore TearRestore Thermal Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2021-01-25

Official Correspondent

Ken DauSchmidt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TearRestore Inc

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 3017978518. Last updated year: 2026. Please use registration number 3017978518 when referencing this establishment in official correspondence.