OptiLight IPL Handpiece NF

GUDID 07290109145303

LUMENIS LTD.

Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system
Primary Device ID07290109145303
NIH Device Record Keybab16c99-fe66-4ede-9067-69ba400c79d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiLight IPL Handpiece NF
Version Model NumberOptiLight IPL Handpiece NF
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
GS107290109145303 [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 Date2021-09-14
Device Publish Date2021-09-06

Devices Manufactured by LUMENIS LTD.

07290109145303 - OptiLight IPL Handpiece NF2021-09-14
07290109145303 - OptiLight IPL Handpiece NF2021-09-14
07290109145143 - UltraPulse® α2021-08-10
07290109144740 - OptiLight IPL Module Kit 2021-08-02
07290109144894 - OPT Filter2021-08-02
07290109144900 - Rosacea I-III Filter2021-08-02
07290109144917 - Rosacea IV-V Filter 2021-08-02
07290109145082 - OPT Module Kit2021-08-02
07290109145099 - OPT Handpiece2021-08-02

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