OtoLase™ Straight Tip SA-20055430

GUDID 17290109146796

SA-20055430 Box: AC-20055380

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system
Primary Device ID17290109146796
NIH Device Record Key2f481a5e-6a37-4a38-892e-96abf1c79e2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOtoLase™ Straight Tip
Version Model NumberOtoLase™ Straight Tip
Catalog NumberSA-20055430
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109146799 [Primary]
GS117290109146796 [Package]
Contains: 07290109146799
Package: [12 Units]
In Commercial Distribution

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-12
Device Publish Date2022-09-04

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.