Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017774717

FEI Number

3017774717

Entity Name

POLETTE LIMITED

City/State/Country

Hong Kong, HK

Establishment Address

18/F, 33 Wyndham Street, Central, Hong Kong 999077, HK

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Polette Limited (Owner Number: 10092712)

Owner / Operator Contact Address

18/F, 33 Wyndham Street, Central, Hong Kong, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lens, Spectacle (Non-Prescription, Sports Performance) Lens, Spectacle (Prescription, Photochromic) Lens, Spectacle (Prescription, Sports Performance) Lens, Spectacle (Non-Prescription, Polarised) Lens, Spectacle (Prescription, Mirrored) Lens, Spectacle (Prescription, for Reading Discomfort) Lens, Spectacle (Non-Prescription, Mirrored) Lens, Spectacle (Non-prescription, Photochromic) Lens, Spectacle (Non-Prescription, Eye Protection) Lens, Spectacle (Non-Prescription, Blue Light Filtering) Lens, Spectacle (Non-prescription, for Reading Discomfort) Lens, Spectacle (Prescription, Blue Light Filtering) Lens, Spectacle (Prescription, Eye Protection) Lens, Spectacle (Prescription, Polarised) Trial Frame Spectacle, Magnifying (Non-Prescription Reading Glasses) Ski Goggle Lens Wipe PD Machine Frame, Spectacle (Sports Frame) Frame, Spectacle Titanium Frame

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2025-02-09
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2025-02-09
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2025-02-09
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2025-02-09
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2025-02-09
HLH	Pupillometer, Manual	Ophthalmic	Class 1	886.1700	2025-02-09
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2025-02-09

Official Correspondent

Coco Chen

US Agent Details

jimmy chen Business: Hyun Turle E-Commerce Inc Email: Kin.grace@hotmail.com Phone: (626) 6273399

Related Public Records

Same Entity

Polette Limited

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
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017774717. Last updated year: 2026. Please use registration number 3017774717 when referencing this establishment in official correspondence.