FDA.reportPublic FDA data

EVOLUTION ST350

Primary DI
00667259003970
Brand
EVOLUTION ST350
Company
Silhouet-Tone Corporation
Model
411103
Published
2025-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCWEpilator, High Frequency, Needle-Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCWEpilator, High Frequency, Needle-TypeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00667259003970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00667259003970006672590039706672590039700667259003970

GMDN Terms#

Term, Definition table
TermDefinition
Hair-removal electrolysis system needle electrode, reusableA device designed as a needle-shaped electrode used together with a hair-removal electrolysis system and used to destroy the dermal papilla (hair root) through application of an electric current from the parent device via the tip of this device that is inserted close to the hair shaft, under the skin, and into the dermal papilla. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-340-9456info@silhouettone.com

Regulatory Flags#

DUNS number
242049828
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00667259004007Laguna Edge (2M)4120052025-11-12
00667259003963EVOLUTION XHD4110272025-07-09
00667259001952Soli-Lite LG2 Spectra4115602018-08-24
00667259001600PR Cell 2G4113212018-08-24
00667259003871ELITE PLATINUM LINAK (BI-V)4122682022-07-19
00667259001563ST2504111012018-08-24
00667259003796EVOLUTION 7HD SEQUENTIAL4110172018-09-17
00667259003901ELITE SERIE MD-100 W/O Accessories Table4122522021-09-09
00667259003918ELITE SERIE MD-100-With 2 Arm Support Table4122532021-09-09
00667259003925ELITE SERIE MD-100-With 2 Stirrups Table4122542021-09-09
00667259003932ETNA TABLE (110V) 27 '' 2'' CUSHION WITH HEADREST4127002021-09-09
00667259003949ETNA SBF TABLE (110V) 27'' 2'' CUSHION WITH HEADREST4127162021-09-09
00667259003956ETNA SBF TABLE (110V) 27'' 4'' CUSHION WITH HEADREST4127182021-09-09
00667259003895Soli-Lite LG4 Galileo4115692020-08-17
00667259000030Laguna Mist Flex with Armrest 230V4120044120042017-06-16
00667259000016Laguna Mist 29' 230V4120024120022017-06-16
00667259000443Laguna Mist Flex with Armrest 230V4120044120042017-06-16
00667259000054Laguna Mist 32'' 230V4120144120142017-06-16
00667259003819ELITE SERIE MD-100-With 2 (Stirups & Arm Support) Table4122552019-04-25
00667259003826ELITE SERIE MD-100-With 2 (Stirups & Ergo Armrest) Table4122572019-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00686209051212ApilusDectro InternationalKCW2026-05-12
00667259003963EVOLUTION XHDSilhouet-Tone CorporationKCW2025-07-09
08800016903317Secret RF Smartcure Applicator With ElectrodesCLASSYS Inc.KCW2024-10-30
00686209051014Pro-TecDectro InternationalKCW2024-10-09
00686209051021Pro-TecDectro InternationalKCW2024-10-09
00686209051038Pro-TecDectro InternationalKCW2024-10-09
00686209051045Pro-TecDectro InternationalKCW2024-10-09
00686209051052Pro-TecDectro InternationalKCW2024-10-09
00686209052011Pro-TecDectro InternationalKCW2024-10-09
00686209052028Pro-TecDectro InternationalKCW2024-10-09
00686209052035Pro-TecDectro InternationalKCW2024-10-09
00686209052042Pro-TecDectro InternationalKCW2024-10-09
00686209052059Pro-TecDectro InternationalKCW2024-10-09
00686209052110Pro-TecDectro InternationalKCW2024-10-09
00686209052127Pro-TecDectro InternationalKCW2024-10-09
00686209052134Pro-TecDectro InternationalKCW2024-10-09
00686209052141Pro-TecDectro InternationalKCW2024-10-09
00686209052158Pro-TecDectro InternationalKCW2024-10-09
00686209100903ApilusDectro InternationalKCW2024-05-23
00686209100910ApilusDectro InternationalKCW2024-05-23
00686209101115ApilusDectro InternationalKCW2024-05-23
00686209106004ApilusDectro InternationalKCW2024-05-23
00686209106059ApilusDectro InternationalKCW2024-05-23
00686209101238ApilusDectro InternationalKCW2024-05-22
00850057194005Elegance+Clareblend, Inc.KCW2023-12-14
00850057194036EleganceClareblend, Inc.KCW2023-12-14
00850057194043G-TechClareblend, Inc.KCW2023-12-14
00850057194050EssenceClareblend, Inc.KCW2023-12-14
00850057194067EZ3Clareblend, Inc.KCW2023-12-14
00850057194074LamprobeClareblend, Inc.KCW2023-12-14