EVOLUTION XHD

GUDID 00667259003963

Silhouet-Tone Corporation

Hair-removal electrolysis system needle electrode, reusable
Primary Device ID00667259003963
NIH Device Record Key50e82268-c0a7-4193-a701-e8e8c901f790
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVOLUTION XHD
Version Model Number411027
Company DUNS242049828
Company NameSilhouet-Tone Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-340-9456
Emailinfo@silhouettone.com
Phone1-866-340-9456
Emailinfo@silhouettone.com
Phone1-866-340-9456
Emailinfo@silhouettone.com
Phone1-866-340-9456
Emailinfo@silhouettone.com
Phone1-866-340-9456
Emailinfo@silhouettone.com
Phone1-866-340-9456
Emailinfo@silhouettone.com
Phone1-866-340-9456
Emailinfo@silhouettone.com
Phone1-866-340-9456
Emailinfo@silhouettone.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100667259003963 [Primary]

FDA Product Code

KCWEpilator, High Frequency, Needle-Type

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-17
Device Publish Date2025-07-09

Devices Manufactured by Silhouet-Tone Corporation

00667259003963 - EVOLUTION XHD2025-07-17
00667259003963 - EVOLUTION XHD2025-07-17
00667259003970 - EVOLUTION ST3502025-07-17
00667259003871 - ELITE PLATINUM LINAK (BI-V)2022-07-27
00667259003901 - ELITE SERIE MD-100 W/O Accessories Table2021-09-17
00667259003918 - ELITE SERIE MD-100-With 2 Arm Support Table2021-09-17
00667259003925 - ELITE SERIE MD-100-With 2 Stirrups Table2021-09-17
00667259003932 - ETNA TABLE (110V) 27 '' 2'' CUSHION WITH HEADREST2021-09-17
00667259003949 - ETNA SBF TABLE (110V) 27'' 2'' CUSHION WITH HEADREST2021-09-17

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