Multi-spot Nd:YAG Treatment Head

GUDID 07290109140353

LUMENIS LTD.

Multi-modality skin surface treatment system
Primary Device ID07290109140353
NIH Device Record Key8866e3ac-9446-485c-90d3-2ec8ea5a48d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-spot Nd:YAG Treatment Head
Version Model NumberMulti-spot Nd:YAG Treatment Head
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

Customer Support Contacts

Phone408-764-3000
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Phone408-764-3000
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Phone408-764-3000
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Phone408-764-3000
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Phone408-764-3000
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Device Identifiers

Device Issuing AgencyDevice ID
GS107290109140353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-23

Devices Manufactured by LUMENIS LTD.

07290109147161 - Lumenis Pulse 120H2025-02-26
07290109147178 - Lumenis Pulse 120H2025-02-26
07290109147185 - Lumenis Pulse, Moses 2.0 (DOM)2025-02-26
07290109147192 - Lumenis Pulse 120H2025-02-26
07290109147208 - Lumenis Pulse, Moses 2.0 (INT)2025-02-26
07290109147215 - Lumenis Pulse 120H2025-02-26
07290109147222 - Lumenis Pulse 120H2025-02-26
07290109147291 - Lumenis Pulse 120H2025-02-26

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