PASCAL Synthesis TwinStar SA-06325

GUDID 00855005006171

PASCAL Synthesis TwinStar (577/638) CONSOLE, PA-03, SYNTHESIS III JAPAN (PACKED)

TOPCON MEDICAL LASER SYSTEMS, INC.

Ophthalmic solid-state laser system, photodisruption
Primary Device ID00855005006171
NIH Device Record Key1c814190-bb69-4ed6-9b26-e35b49900c81
Commercial Distribution StatusIn Commercial Distribution
Brand NamePASCAL Synthesis TwinStar
Version Model NumberPASCAL Synthesis 577 /638
Catalog NumberSA-06325
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

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100855005006171 [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 TwinStar]

00855005006188PASCAL Synthesis TwinStar (577/638) CONSOLE, PA-03, SYNTHESIS III (PACKED)
00855005006171PASCAL Synthesis TwinStar (577/638) CONSOLE, PA-03, SYNTHESIS III JAPAN (PACKED)
00855005006263PASCAL Synthesis TwinStar (577/638), PA-04, JAPAN (PACKED)
00855005006232PASCAL Synthesis TwinStar (577/638), PA-04 (PACKED)

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