xeo SA

GUDID 00816722021113

xeo SA IPL System

CUTERA, INC.

Multi-modality skin surface treatment system
Primary Device ID00816722021113
NIH Device Record Keyf1cd1cdb-ce28-4973-9a0e-92accfa46402
Commercial Distribution StatusIn Commercial Distribution
Brand Namexeo SA
Version Model Numberxeo SA
Company DUNS041071643
Company NameCUTERA, INC.
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

Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816722021113 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

Devices Manufactured by CUTERA, INC.

00816722022806 - Acutip2023-05-23 Acutip IPL Handpiece for xeo+/xeo+ SA
00816722021809 - xeo+2022-12-08 xeo+ Laser System
00816722021816 - xeo+ SA2022-12-08 xeo+ SA IPL System
00816722022813 - Limelight 2022-12-08 Limelight IPL Handpiece for xeo+/xeo+ SA
00816722022820 - Prowave 2022-12-08 Prowave IPL Handpiece for xeo+/xeo+ SA
00816722022837 - Titan2022-12-08 Titan IPL Handpiece for xeo+/xeo+ SA
00816722022844 - Pearl Fractional2022-12-08 Pearl Fractional Laser Handpiece for xeo+/xeo+ SA
00816722022479 - truSculpt 2 RF handpiece2022-11-22 truSculpt 2 cm^2 handheld handpiece for use with truSculpt iD RF device

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