OPTOPOL USA

FDA Device Registration & Listing · Raleigh, NC, US · Registration 3016965602

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
3016965602
FEI Number
3016965602
Entity Name
OPTOPOL USA
City/State/Country
Raleigh, NC, US
Establishment Address
3915 Beryl Rd Ste 130, Raleigh, NC 27607, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Optopol USA (Owner Number: 10075002)
Owner / Operator Contact Address
3915 Beryl Rd Ste 130, Raleigh, NC 27607, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PTS 2000 PTS 925

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HPT Perimeter, Automatic, Ac-Powered Ophthalmic Class 1 886.1605 2025-05-04

Official Correspondent

Jade King

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Optopol USA
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 3016965602. Last updated year: 2026. Please use registration number 3016965602 when referencing this establishment in official correspondence.
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