TOPCON MEDICAL LASER SYSTEMS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3008599994	3008599994	TOPCON MEDICAL LASER SYSTEMS, INC.	1	N	2020-04-25	606 Enterprise Ct Livermore CA US 94550

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00855005006102	PASCAL Laser Indirect Ophthalmoscope - KIT, PASCAL LIO, GREEN, PASCAL STREAMLINE B RELEASE (532)	+1(888)850-1223	tmlsservice@topcon.com
00855005006119	PASCAL Laser Indirect Ophthalmoscope - KIT, PASCAL LIO, YELLOW, PASCAL STREAMLINE B RELEASE (577)	+1(888)850-1223	tmlsservice@topcon.com
00855005006126	PASCAL Laser Indirect Ophthalmoscope - KIT, PASCAL LIO, 532 nm PASCAL SYNTHESIS D RELEASE	+1(888)850-1223	tmlsservice@topcon.com

topcon.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
121095	1036029360	K170409	PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System	GEX	2017-09-12
121095	1973491672	K123542	PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER	HQF	2013-05-15
121095	1867057598	K123056	PASCAL LASER INDIRECT OPHTHALMOSCOPE	HQF	2012-11-13
121095	1635204245	K111108	PASCAL STREAMLINE 577 (WITH ACCESSORIES)	HQF	2011-08-11
121095	1148828627	K100019	PASCAL STREAMLINE PHOTOCOAGULATOR	HQF	2010-05-04
121095	1962706677	K092621	PASCAL STREAMLINE PHOTOCOAGULATOR	HQF	2009-09-25
121095	1270596842	K091666	PASCAL PHOTOCOAGULATOR, PASCAL-US	GEX	2009-07-15
121095	1887788046	K081744	PASCAL SYNTHESIS DELIVERY SYSTEM	GEX	2008-09-09
121095	2054074796	K062336	OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE	GEX	2006-10-19
121095	1429130769	K043486	PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01	GEX	2005-03-03
121095	1358570405

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GEX	5	2017-09-12
HQF	5	2013-05-15

PMN#

PSLT With PASCAL Synthesis, PSLT With PASCAL Synthesis TwinStar
2018-05-25
Topcon Medical Laser Systems, Inc.
PSLT For PASCAL Streamline
2017-11-27
Topcon Medical Laser Systems, Inc.

GUDID#

Head-Up-Display, HUD-1 - Head-Up-Display, HUD-1, Ophthalmic Projector
TOPCON MEDICAL LASER SYSTEMS, INC.
2018-02-12
PASCAL Laser Indirect Ophthalmoscope - KIT, PASCAL LIO, GREEN, PASCAL STREAMLINE B RELEASE (532)
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Laser Indirect Ophthalmoscope - KIT, PASCAL LIO, YELLOW, PASCAL STREAMLINE B RELEASE (577)
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Laser Indirect Ophthalmoscope - KIT, PASCAL LIO, 532 nm PASCAL SYNTHESIS D RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Laser Indirect Ophthalmoscope - KIT, PASCAL LIO, 577nm, PASCAL SYNTHESIS D RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Laser Indirect Ophthalmoscope - KIT, PASCAL LIO, GREEN, PASCAL B RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis TwinStar - PASCAL Synthesis TwinStar (577/638), PA-04 (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
2019-09-17
PACSAL Synthesis - PASCAL Synthesis (532), Green, PA-04 (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
2019-09-17
PASCAL Synthesis - PASCAL Synthesis (577), Yellow, PA-04 (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
2019-09-17
PASCAL Synthesis TwinStar - PASCAL Synthesis TwinStar (577/638), PA-04, JAPAN (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
2019-09-17
PACSAL Synthesis - PASCAL Synthesis (532), Green, PA-04, JAPAN (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
2019-09-17
PACSAL Synthesis - PASCAL Synthesis (577), Yellow, PA-04, JAPAN (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
2019-09-17
PASCAL Synthesis - (532) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis - (577) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis - (532) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis - (577) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis - Synthesis SLC & ESF (532nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher A
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis - Synthesis SLC & ESF (577nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher B
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis - PASCAL Synthesis SLC & ESF (532 nm) for BM C RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis - PASCAL Synthesis SLC & ESF (577 nm) for BM B1 RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis - PASCAL Synthesis SLC & ESF (532 nm) for BQ B1 RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis - PASCAL Synthesis SLC & ESF (577 nm) for BQ B1 RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis - (532) CONSOLE PA-03, PB-2, SYNTHESIS III, JAPAN (PACKED) RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis - (577) CONSOLE PA-03, PB-2, SYNTHESIS III, JAPAN (PACKED) RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
2016-04-15
PASCAL Synthesis TwinStar - PASCAL Synthesis TwinStar (577/638) CONSOLE, PA-03, SYNTHESIS III JAPAN (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
2017-10-04
PASCAL Synthesis TwinStar - PASCAL Synthesis TwinStar (577/638) CONSOLE, PA-03, SYNTHESIS III (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
2017-10-04
PASCAL Synthesis - PASCAL Synthesis, ASSY, SLC AND ESF, 532nm, SYNTHESIS III, TOPCON D7 aka SA-06174
TOPCON MEDICAL LASER SYSTEMS, INC.
2017-10-04
PASCAL Synthesis - PASCAL Synthesis, ASSY, SLC AND ESF, 577nm, SYNTHESIS III, TOPCON D7 aka SA-06175
TOPCON MEDICAL LASER SYSTEMS, INC.
2017-10-04