PACSAL Synthesis SA-06456

GUDID 00855005006270

PASCAL Synthesis (532), Green, PA-04, JAPAN (PACKED)

TOPCON MEDICAL LASER SYSTEMS, INC.

Ophthalmic solid-state laser system, photodisruption
Primary Device ID00855005006270
NIH Device Record Key220ec7e4-5c2b-4cf8-9efb-03ec2b55c1b2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePACSAL Synthesis
Version Model NumberPASCAL Synthesis 532- PA04
Catalog NumberSA-06456
Company DUNS041376321
Company NameTOPCON MEDICAL LASER SYSTEMS, INC.
Device Count1
DM Exempttrue
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
Emailssrivastava@topcon.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100855005006270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-18
Device Publish Date2019-09-17

On-Brand Devices [PACSAL Synthesis]

00855005006287PASCAL Synthesis (577), Yellow, PA-04, JAPAN (PACKED)
00855005006270PASCAL Synthesis (532), Green, PA-04, JAPAN (PACKED)
00855005006249PASCAL Synthesis (532), Green, PA-04 (PACKED)

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