OCuSOFT LLC

FDA Device Registration & Listing · Rosenberg, TX, US · Registration 1641445

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
1641445
FEI Number
1641445
Entity Name
OCuSOFT LLC
City/State/Country
Rosenberg, TX, US
Establishment Address
30444 Southwest Fwy bldg. B, Rosenberg, TX 77471, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
OCuSOFT LLC (Owner Number: 10094687)
Owner / Operator Contact Address
30444 Southwest Fwy, Rosenberg, TX 77471, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Tear Pool Dissolvable Punctum Plugs Thermal 1-Touch

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZU Plug, Punctum Unknown Class U N/A 2025-12-16
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2025-12-16

Official Correspondent

George Haines

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OCuSOFT LLC
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
K881862 Thermo Body Wrap Systems, Inc. THERMO-BODY-WRAP SYSTEM 1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1641445. Last updated year: 2026. Please use registration number 1641445 when referencing this establishment in official correspondence.
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