Data / Medical devices / Canada / Silhouet-Tone Corporation
Silhouet-Tone Corporation: FDA-registered device maker in LAVAL Quebec, Canada, 3 510(k) clearances
Silhouet-Tone Corporation is registered with the FDA (registration 3005545844) in LAVAL Quebec, Canada. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 20, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005545844
- Address
- 2185 Rue Michelin, LAVAL Quebec, Canada, H7L5B8
- Owner or operator
- Silhouet-Tone Corporation (8020371)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- January 11, 2006
- Registered through
- 2027
- Brand names listed
- Blend ST 250, Elantra, Elite Bronze, Elite Bronze Double Hydraulic, Elite Platinum, Elite Silver Star, Elite series MD-100, Escape and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Chair And Table, Medical | KMN | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Chair, Surgical, Ac-Powered | GBB | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Epilator, High Frequency, Needle-Type | KCW | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Table, Examination, Medical, Powered | LGX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 20, 2019 | K192755 | Soli-Lite LG4 Galileo | GEX | Substantially Equivalent | Silhouet-Tone Corporation | accessdata.fda.gov |
| February 12, 2016 | K153718 | Spirit Hair Removal laser Family | GEX | Substantially Equivalent | Active Optical Systems , Ltd. | accessdata.fda.gov |
| July 29, 2010 | K102050 | Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 | GEX | Substantially Equivalent | Advanced Technology Laser Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Chair And Table, Medical
- All makers of Brush, Dermabrasion, Powered
- All makers of Chair, Surgical, Ac-Powered
- All makers of Powered Laser Surgical Instrument
- All makers of Table, Examination, Medical, Powered
Updated December 20, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.