Aura PT

GUDID 04712826770536

LIGHTMED CORPORATION

General/multiple surgical frequency-doubled solid-state laser system
Primary Device ID04712826770536
NIH Device Record Keyf3292894-ab0b-45b6-8a66-6cc97a97fdec
Commercial Distribution StatusIn Commercial Distribution
Brand NameAura PT
Version Model NumberYL0015
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
GS104712826770536 [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

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04712826770819 - TruScan Pro2021-04-21
04712826770826 - TruScan Pro2021-04-21
04712826770833 - TruScan Pro2021-04-21
04712826770840 - TruScan Pro2021-04-21

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