LABO AMERICA

FDA Device Registration & Listing · Fremont, CA, US · Registration 3009560832

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
3009560832
FEI Number
3009560832
Entity Name
LABO AMERICA
City/State/Country
Fremont, CA, US
Establishment Address
920 Auburn Ct, Fremont, CA 94538, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Labo America (Owner Number: 10040536)
Owner / Operator Contact Address
920 Auburn Ct, Fremont, CA 94538, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LABOMED LABOMED

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSO Microscope, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4700 2013-12-26
HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic General, Plastic Surgery Class 1 878.4700 2013-12-26

Official Correspondent

Gautam Aggarwal

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Labo America
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 3009560832. Last updated year: 2026. Please use registration number 3009560832 when referencing this establishment in official correspondence.
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