Topcon Medical Laser Systems Inc

FDA Filings

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

FDA Registration(s)
Registration Number3008599994
FEI Number3008599994
NameTOPCON MEDICAL LASER SYSTEMS, INC.
Owner & OperatorTopcon Medical Laser Systems, Inc.
Contact Address606 Enterprise Court
Livermore CA 94550 US
Official Correspondent
  • Sweta Srivastava
  • x-925-2457721-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address606 Enterprise Ct
Livermore, CA 94550 US
Establishment Type
  • Remanufacture Medical Device
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
TOPCON MEDICAL LASER SYSTEMS, INC.
PACSAL Synthesis SA-064572019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PACSAL Synthesis SA-064562019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis TwinStar SA-064532019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-064552019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PACSAL Synthesis SA-064542019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis TwinStar SA-064522019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
Head-Up-Display, HUD-1 SA-064272019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-064152019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-064142019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis TwinStar SA-062882019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis TwinStar SA-063252019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-064102019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-064092019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Laser Indirect Ophthalmoscope SA-062012019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Laser Indirect Ophthalmoscope SA-061722019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Laser Indirect Ophthalmoscope SA-061712019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Laser Indirect Ophthalmoscope SA-061622019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Laser Indirect Ophthalmoscope SA-061612019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-061962019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-061942019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-061972019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-061952019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-063772019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-063762019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-062852019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-062842019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-062812019-11-18
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis SA-062802019-11-18
Topcon Medical Laser Systems, Inc.
PSLT With PASCAL Synthesis, PSLT With PASCAL Synthesis TwinStar2018-05-25
TOPCON MEDICAL LASER SYSTEMS, INC.
Head-Up-Display, HUD-12017-12-26
Topcon Medical Laser Systems, Inc.
PSLT For PASCAL Streamline2017-11-27
TOPCON MEDICAL LASER SYSTEMS, INC.
Pascal Synthesis TwinStar Ophthalmic Scanning Laser System2017-09-25
TOPCON MEDICAL LASER SYSTEMS, INC.
Pascal Synthesis TwinStar Ophthalmic Scanning Laser System2017-09-25
TOPCON MEDICAL LASER SYSTEMS, INC.
Pascal Synthesis2013-09-16
TOPCON MEDICAL LASER SYSTEMS, INC.
Pascal Synthesis2013-09-16
TOPCON MEDICAL LASER SYSTEMS, INC
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER2013-05-15
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Laser Indirect Ophthalmoscope2012-11-14
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Streamline 5772011-08-24
TOPCON MEDICAL LASER SYSTEMS, INC
PASCAL STREAMLINE 577 (WITH ACCESSORIES)2011-08-11
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Streamline Photocoagulator2010-11-24
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Streamline Photocoagulator2010-11-24
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Photocoagulator, PASCAL-US2010-11-24
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis Delivery System2010-11-24
TOPCON MEDICAL LASER SYSTEMS, INC.
Laser Indirect Ophthalmoscope2010-11-24
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Photocoagulator, Product-PASCAL-012010-09-13
TOPCON MEDICAL LASER SYSTEMS, INC
PASCAL STREAMLINE PHOTOCOAGULATOR2009-09-25
TOPCON MEDICAL LASER SYSTEMS, INC
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-012005-03-03

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