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Data / Medical devices / United States / Pdo Max

Pdo Max: FDA-registered device maker in Liverpool, NY, United States, 3 510(k) clearances

Pdo Max is registered with the FDA (registration 3015289316) in Liverpool, NY, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 12, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3015289316
Address
4971 Bear Road Suite 102, Liverpool, NY, United States, 13088
Owner or operator
PDO MAX (10060757)
Roles
Complaint file establishment, Specification developer
First device listed
June 20, 2019
Registered through
2026
Brand names listed
Lumenvy Skincare Valluxia LED Mask, PDO MAXX Threads, PDO Max Cannulas, PDO Max Dual Needle, REJUVN8 Threads

Devices it lists

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
January 12, 2024K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)OHSSubstantially EquivalentShenzhen Idea Light Limitedaccessdata.fda.gov
December 17, 2021K210871PDO Max Suture with Dual NeedleNEWSubstantially EquivalentPdo Max, Inc.accessdata.fda.gov
June 4, 2019K190245PDS Barbed Suture, PDO MAXX ThreadsNEWSubstantially EquivalentPdo Max, Inc.accessdata.fda.gov

Compare with other makers

Updated January 12, 2024. 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.