xeo

GUDID 00816722021106

xeo Laser System

CUTERA, INC.

Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system
Primary Device ID00816722021106
NIH Device Record Key70abe761-d138-4e84-91a0-a557fb7a25cd
Commercial Distribution StatusIn Commercial Distribution
Brand Namexeo
Version Model Numberxeo
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
GS100816722021106 [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.

00816722022479 - truSculpt 2 RF handpiece2022-11-22 truSculpt 2 cm^2 handheld handpiece for use with truSculpt iD RF device
00816722022486 - truSculpt 5 RF handpiece2022-11-22 truSculpt 4.5 cm^2 handheld handpiece for use with truSculpt iD RF device
00816722021700 - AviClear2022-04-11 AviClear Laser System
00816722022707 - AviClear2022-04-11 AviClear Laser Handpiece
00816722022363 - CoolView2020-02-12 CoolView Laser Handpiece for EV+ (EV3)
00816722021007 - CoolGlide CV2020-02-06 CoolGlide CV Laser System
00816722021014 - CoolGlide Excel2020-02-06 CoolGlide Excel Laser System
00816722021021 - CoolGlide Vantage2020-02-06 CoolGlide Vantage Laser System

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