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Data / Medical devices / United States / W And R Investments, LLC

W And R Investments, LLC: FDA-registered device maker in Milford, MA, United States, 2 510(k) clearances

W And R Investments, LLC is registered with the FDA (registration 3009593803) in Milford, MA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 30, 2021. Registered through 2026. FDA data exported November 2, 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
3009593803
Address
113 Cedar Street Suite S5, Milford, MA, United States, 01757
Owner or operator
W and R Investments dba Laser Engineering (10044040)
Roles
Manufacturer
First device listed
April 22, 2013
Registered through
2026
Brand names listed
UltraLase Flexible CO2 Laser Waveguide, UltraLase Flexible Laser Waveguide

Devices it lists

DeviceProduct codeClassRoleSource
Powered Laser Surgical InstrumentGEX2Manufactureraccessdata.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
July 30, 2021K211761UltraLase Flexible CO2 Laser WaveguideGEXSubstantially EquivalentW & R Investments, LLC Dba Laser Engineeringaccessdata.fda.gov
October 21, 2011K112166ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDEGEXSubstantially EquivalentW and R Investments Dba Laser Engineeringaccessdata.fda.gov

Compare with other makers

Updated July 30, 2021. 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.