OPT Handpiece

GUDID 07290109145099

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 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 ID07290109145099
NIH Device Record Key8c591c0a-44cf-4013-9b27-cb7f19857b51
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPT Handpiece
Version Model NumberOPT Handpiece
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109145099 [Primary]

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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