Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010949612

FEI Number

3010949612

Entity Name

ALPHAMICRON, INC

City/State/Country

Kent, OH, US

Establishment Address

1950 State Route 59, Kent, OH 44240, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

AlphaMicron, Inc (Owner Number: 10055113)

Owner / Operator Contact Address

1950 State Route 59, Kent, OH 44240, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CTRL-MX CS02 MS02 MS02L CS03 CTRL-M1 CTRL-ONE CTRL-MXL CTRL MS1 CTRL-M1L CTRL-XC CTRL-XC-F CTRL-M1-FA CTRL-MX-FA CS02-F MS02-F-MBlk CS03-F CTRL-MX-F MS02-FA-MBlk CS02-FA CTRL-M1-F MS02-FA MS02-F CS03-FA CTRL-XC-FA MS1-F MS1-FA MS1-FA-MBlk

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	2017-06-08
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2017-06-08

Official Correspondent

Ashley Klingelheber

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AlphaMicron, 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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3009141079	STAGE	Sandy, UT, US
3013857947	FARFETCH ITALIA S.R.L.	MILAN Milano, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010949612. Last updated year: 2026. Please use registration number 3010949612 when referencing this establishment in official correspondence.