Stellar M22 Q-switched Nd:YAG upgrade

GUDID 07290109144788

LUMENIS LTD.

Multi-modality skin surface treatment system
Primary Device ID07290109144788
NIH Device Record Keyc7014ea9-d034-4d33-a489-2e0696d8e316
Commercial Distribution StatusIn Commercial Distribution
Brand NameStellar M22 Q-switched Nd:YAG upgrade
Version Model NumberQ-switched Nd:YAG upgrade
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 Kittrue
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
GS107290109144788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

Devices Manufactured by LUMENIS LTD.

07290109144788 - Stellar M22 Q-switched Nd:YAG upgrade2020-02-11
07290109144788 - Stellar M22 Q-switched Nd:YAG upgrade2020-02-11
07290109144771 - Stellar M22 Multi-Spot Nd:YAG upgrade2020-02-11
07290109142654 - SurgiTouch™ Upgrade kit for UltraPulse® 2019-11-08 Additional DM UDI: 07290109144252
07290109142623 - SurgiTouch™ Upgrade kit for UltraPulse® SurgiTouch™2019-11-08 Additional DM UDI: 07290109144252
07290109142616 - SurgiTouch™ Upgrade kit for UltraPulse® SurgiTouch™2019-11-08 Additional DM UDI: 07290109144252
07290109142593 - SurgiTouch™ Upgrade kit for UltraPulse® SurgiTouch™2019-11-08 Additional DM UDI: 07290109144252
07290109142586 - SurgiTouch™ Upgrade kit for UltraPulse® 2019-11-08 Additional DM UDI: 07290109144252
07290109142456 - MicroSwitch Joystick2019-11-08 Additional DM UDI: 07290109144252

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