Opti-Tip Treatment Kit

GUDID 07290109145259

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 ID07290109145259
NIH Device Record Keyfb0c071e-850a-4a1d-ab95-f75269c81fbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpti-Tip Treatment Kit
Version Model NumberOpti-Tip 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
GS107290109145259 [Primary]
GS117290109145256 [Package]
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 Date2021-08-02
Device Publish Date2021-07-25

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