Stellar Optima Treatment Kit

GUDID 17290109145126

LUMENIS LTD.

Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit Intense pulsed light dry eye therapy unit
Primary Device ID17290109145126
NIH Device Record Key90e29ad9-cca0-4347-945e-9e8e72d37b75
Commercial Distribution StatusIn Commercial Distribution
Brand NameStellar Optima Treatment Kit
Version Model NumberStellar Optima Treatment Kit
Company DUNS600166524
Company NameLUMENIS LTD.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS107290109145129 [Primary]
GS117290109145126 [Package]
Contains: 07290109145129
Package: [48 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIUIntense Pulsed Light Device For Managing Dry Eye

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-21
Device Publish Date2021-04-13

Devices Manufactured by LUMENIS LTD.

07290118853701 - Lumenis Pulse 60H, 60Hz2023-12-18
07290109144924 - Stellar SapphireCool LG 6mm2023-08-16
07290109144931 - Stellar SapphireCool LG 15x352023-08-16
07290109144948 - Stellar SapphireCool LG 8x152023-08-16
07290109146676 - SurgiTouch Scanner 2022-09-30
07290109146133 - UltraPulse® DUO2022-09-28 UltraPulse DUO
07290109147055 - VersaPulse PowerSuite 80/100W2022-09-27
07290109147062 - VersaPulse PowerSuite 80/100W2022-09-27

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