Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008345156

FEI Number

3008345156

Entity Name

SILHOUETTE INTERNATIONAL SCHMIED AG

City/State/Country

Linz Oberosterreich, AT

Establishment Address

Ellbognerstrasse 24, Linz Oberosterreich A-4021, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Silhouette International Schmied AG (Owner Number: 10032182)

Owner / Operator Contact Address

Ellbognerstrasse 24, Linz, AT-NOTA A-4021, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Silhouette neubau Silhouette Evil Eye neubau Silhouette Vision Sensation Panorama Lenses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2010-04-16
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2010-04-16
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2017-10-13

Official Correspondent

David Laing

US Agent Details

David Laing Business: Silhouette International Schmied AG Email: d.laing@us.silhouette.com Phone: (518) 2703107

Related Public Records

Same Entity

Silhouette International Schmied AG

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
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

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3009554831	ROGER EYE DESIGN	Etten-Leur Noord-Brabant, NL
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008345156. Last updated year: 2026. Please use registration number 3008345156 when referencing this establishment in official correspondence.