LightMed TruScan 577

GUDID 04712826770680

The TruScan 577 is a laser system included laser console with pattern scanning laser delivery unit and ophthalmic powered table. There are three boxs

LIGHTMED CORPORATION

Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system Scanning-laser retinal imaging system
Primary Device ID04712826770680
NIH Device Record Key1a069be2-6a57-4508-86de-1dc71052ca9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLightMed TruScan 577
Version Model NumberML0015
Company DUNS657731175
Company NameLIGHTMED CORPORATION
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104712826770680 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by LIGHTMED CORPORATION

04712826770772 - TruScan Pro2021-04-21
04712826770789 - TruScan Pro2021-04-21
04712826770796 - TruScan Pro2021-04-21
04712826770802 - TruScan Pro2021-04-21
04712826770819 - TruScan Pro2021-04-21
04712826770826 - TruScan Pro2021-04-21
04712826770833 - TruScan Pro2021-04-21
04712826770840 - TruScan Pro2021-04-21

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