THE GEM GROUP, INC.

FDA Device Registration & Listing · Lawrence, MA, US · Registration 3001366179

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
3001366179
FEI Number
3001366179
Entity Name
THE GEM GROUP, INC.
City/State/Country
Lawrence, MA, US
Establishment Address
9 International Way, Lawrence, MA 01843, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
The Gem Group, Inc. (Owner Number: 10094790)
Owner / Operator Contact Address
9 International Way, Lawrence, MA 01843, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CapeShades Classic Sunglasses

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 2025-12-23

Official Correspondent

Mike Braley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Gem Group, Inc.
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 3001366179. Last updated year: 2026. Please use registration number 3001366179 when referencing this establishment in official correspondence.
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