UltraPulse Focused Incisional HandPiece set

GUDID 07290109144511

Additional DM UDI: 07290109144528

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system

Primary Device ID	07290109144511
NIH Device Record Key	2fe48f55-20b7-4ff1-a3ab-fc4a2728d8f5
Commercial Distribution Status	In Commercial Distribution
Brand Name	UltraPulse Focused Incisional HandPiece set
Version Model Number	UltraPulse Focused Incisional HandPiece set
Company DUNS	600166524
Company Name	LUMENIS LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109144511 [Direct Marking]
GS1	07290109145075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K203544

FDA Product Code

GEX	Powered Laser Surgical Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

[07290109144511]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-01-21
Device Publish Date	2021-01-13

Devices Manufactured by LUMENIS LTD.

07290118853701 - Lumenis Pulse 60H, 60Hz	2023-12-18
07290109144924 - Stellar SapphireCool LG 6mm	2023-08-16
07290109144931 - Stellar SapphireCool LG 15x35	2023-08-16
07290109144948 - Stellar SapphireCool LG 8x15	2023-08-16
07290109146676 - SurgiTouch Scanner	2022-09-30
07290109146133 - UltraPulse® DUO	2022-09-28 UltraPulse DUO
07290109147055 - VersaPulse PowerSuite 80/100W	2022-09-27
07290109147062 - VersaPulse PowerSuite 80/100W	2022-09-27

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