LEAFAEL LLC

FDA Device Registration & Listing · Needham, MA, US · Registration 3027395807

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
3027395807
FEI Number
3027395807
Entity Name
LEAFAEL LLC
City/State/Country
Needham, MA, US
Establishment Address
68 Emerson Road, Needham, MA 02492, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Leafael LLC (Owner Number: 10088097)
Owner / Operator Contact Address
68 Emerson Road, Needham, MA 02492, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LEAFAEL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HQY Sunglasses (Non-Prescription Including Photosensitive) Ophthalmic Class 1 886.5850 2023-05-24

Official Correspondent

Guofeng Ye

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Leafael 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
K940726 Jay-Y Enterprises Co., Inc. NONE-GENERIC 1994-04-11
K934837 Simon Marketing, Inc. SUNGLASSES 1993-12-08
K852902 Yours Enterprise Co., Ltd. METALLIC SUNGLASSES 1985-08-12
K970895 Custom Optical Frames, Inc. CUSTOM OPTICAL SUNGLASS FRAMES 1997-05-06
K853921 Winsburn Company , Ltd. ALL KINDS OF SUNGLASSES 1985-10-15

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027395807. Last updated year: 2026. Please use registration number 3027395807 when referencing this establishment in official correspondence.
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