PASCAL Synthesis SA-06414

GUDID 00855005006195

PASCAL Synthesis, ASSY, SLC AND ESF, 532nm, SYNTHESIS III, TOPCON D7 aka SA-06174

TOPCON MEDICAL LASER SYSTEMS, INC.

Ophthalmic solid-state laser system, photodisruption
Primary Device ID00855005006195
NIH Device Record Key646d4d35-bb4d-4af2-b2d1-759b243e6bc5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePASCAL Synthesis
Version Model NumberPASCAL Synthesis 532
Catalog NumberSA-06414
Company DUNS041376321
Company NameTOPCON MEDICAL LASER SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)850-1223
Emailtmlsservice@topcon.com

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100855005006195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQFLaser, ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-18
Device Publish Date2017-10-04

On-Brand Devices [PASCAL Synthesis]

00855005006201PASCAL Synthesis, ASSY, SLC AND ESF, 577nm, SYNTHESIS III, TOPCON D7 aka SA-06175
00855005006195PASCAL Synthesis, ASSY, SLC AND ESF, 532nm, SYNTHESIS III, TOPCON D7 aka SA-06174
00855005006164(577) CONSOLE PA-03, PB-2, SYNTHESIS III, JAPAN (PACKED) RELEASE
00855005006157(532) CONSOLE PA-03, PB-2, SYNTHESIS III, JAPAN (PACKED) RELEASE
00855005006096PASCAL Synthesis SLC & ESF (577 nm) for BQ B1 RELEASE
00855005006089PASCAL Synthesis SLC & ESF (532 nm) for BQ B1 RELEASE
00855005006072PASCAL Synthesis SLC & ESF (577 nm) for BM B1 RELEASE
00855005006065PASCAL Synthesis SLC & ESF (532 nm) for BM C RELEASE
00855005006058Synthesis SLC & ESF (577nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher B
00855005006041Synthesis SLC & ESF (532nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher A
00855005006034(577) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE
00855005006027(532) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE
00855005006010(577) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE
00855005006003(532) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE
00855005006256PASCAL Synthesis (577), Yellow, PA-04 (PACKED)

Trademark Results [PASCAL Synthesis]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PASCAL SYNTHESIS
PASCAL SYNTHESIS
85969450 4732172 Live/Registered
TOPCON MEDICAL LASER SYSTEMS, INC.
2013-06-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.