SILHOUET-TONE CORPORATION

FDA Device Registration & Listing · LAVAL Quebec, CA · Registration 3005545844

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005545844
FEI Number
3005545844
Entity Name
SILHOUET-TONE CORPORATION
City/State/Country
LAVAL Quebec, CA
Establishment Address
2185 Rue Michelin, LAVAL Quebec H7L5B8, CA
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Silhouet-Tone Corporation (Owner Number: 8020371)
Owner / Operator Contact Address
1985 Monterey, Laval, CA-QC H7L 3T6, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K153718
PMA Number
N/A

All Registered Proprietary Names

Evolution5HD Ibis Epilator Needle Blend ST 250 Evolution 7HD Sequential Evolution XHD Evolution ST350 Soli-Lite LG2 Lumimax Lumimax Soli-Lite LG4 Galileo Vortex Peel Silver Peel Essential Peel Versalis Peel Elite Silver Star Laguna Mist Flex with armrest Elite series MD-100 Elite Bronze Double Hydraulic Elite Bronze Elite Platinum Spirit - 918

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KCW Epilator, High Frequency, Needle-Type General, Plastic Surgery Class 1 878.5350 2006-01-11
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2017-11-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-08-13
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2020-08-13
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 2013-12-17
GBB Chair, Surgical, Ac-Powered General, Plastic Surgery Class 1 878.4960 2009-03-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-03-24

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Silhouet-Tone Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1225072 SILHOUET-TONE USA Miami, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K954031 R. A. Fischer Co. Corp. COMPU-BLEND EPILATOR 1996-01-05
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005545844. Last updated year: 2026. Please use registration number 3005545844 when referencing this establishment in official correspondence.
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