Moleculight Inc

FDA Filings

This page includes the latest FDA filings for Moleculight Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014704068
• FEI Number: 3014704068
• Name: Martha Yannessa
• Owner & Operator: MolecuLight Inc.
• Contact Address: 425 UNIVERSITY AVE ; TORONTO CA-ON Ontario M5G1T6 CA
• Official Correspondent:
  • TYLER CHACKOWICZ
  • 1-647-3624684-x
• US Agent:
  • Martha Yannessa
  • 412 2606857
  • myannessa@moleculight.com
• Importing Logistics Registration:
  • Importer: MolecuLight Corp.
  • Address: 209-2403 Sidney St. ; Pittsburgh, PA 15203 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 209-2403 Sidney St. ; Pittsburgh, PA 15203 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K213840 MolecuLight, Inc.	MolecuLight I:X	2022-05-18
GUDID 00628110259387 MolecuLight Inc	MolecuLightDX System	2022-01-12
GUDID 00628110259325 MolecuLight Inc	MolecuLight i:X System	2022-01-12
PMN K211901 MolecuLight Inc.	MolecuLightDX	2021-07-21
PMN K191371 | QJF Martha Yannessa [MolecuLight Inc.]	MolecuLight i:X	2019-12-13
PMN K191371 | QJF Martha Yannessa [MolecuLight Inc.]	MolecuLight WoundStickers	2019-12-13
PMN K191371 | QJF Martha Yannessa [MolecuLight Inc.]	MolecuLight DarkDrape	2019-12-13
PMN K191371 | FXN Martha Yannessa [MolecuLight Inc.]	MolecuLight i:X	2019-12-13
PMN K191371 | FXN Martha Yannessa [MolecuLight Inc.]	MolecuLight WoundStickers	2019-12-13
PMN K191371 | FXN Martha Yannessa [MolecuLight Inc.]	MolecuLight DarkDrape	2019-12-13
PMN K191371 MolecuLight Inc.	MolecuLight I:X	2019-12-04
De Novo DEN180008 MolecuLight Inc.	MolecuLight I:X	2018-07-31