Skip to the page

Data / Medical devices / United States / Nouveau Eyewear, Inc.

Nouveau Eyewear, Inc.: FDA-registered device maker in Carrollton, TX, United States, 2 510(k) clearances

Nouveau Eyewear, Inc. is registered with the FDA (registration 1642130) in Carrollton, TX, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 5, 1992. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
1642130
Address
2853 EISENHOWER ST., Suite 100, Carrollton, TX, United States, 75007
Owner or operator
Walman Optical (9095380)
Roles
Repackager or relabeler, Specification developer
First device listed
October 27, 2009
Registered through
2026
Brand names listed
Nouveau Eyewear

Devices it lists

DeviceProduct codeClassRoleSource
Frame, SpectacleHQZ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Sunglasses (Non-Prescription Including Photosensitive)HQY1Repackager or relabeler, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 5, 1992K924232SPECTACLE FRAMESHQZSubstantially EquivalentAptaker Co., Inc.accessdata.fda.gov
September 17, 1990K903739SUNGLASSES W/NON PRESCRIPT LENSES W/PHOTO SENSITIVHQYSubstantially EquivalentNouveau Eyewearaccessdata.fda.gov

Compare with other makers

Updated November 5, 1992. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.