FDA Registration
Active
🇨🇦 Canada
SILHOUET-TONE CORPORATION
Reg #: 3005545844
·
FEI: 3005545844
·
Expires 2026
Products
8
Proprietary Names
41
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- SILHOUET-TONE CORPORATION
- Registration Number
- 3005545844
- FEI Number
- 3005545844
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2185 Rue Michelin
- City
- LAVAL Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K192755
Owner / Operator
- Firm Name
- Silhouet-Tone Corporation
- Operator Number
- 8020371
- Address
- 1985 Monterey
- City
- Laval
- State
- Quebec
- Postal Code
- H7L 3T6
- Country
- CA
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- 757
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Epilator, High Frequency, Needle-Type | KCW | Class 1 | General, Plastic Surgery | No | 2006-01-11 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2017-11-30 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2020-08-13 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2013-12-17 |
| Chair, Surgical, Ac-Powered | GBB | Class 1 | General, Plastic Surgery | No | 2009-03-02 |
| Table, Examination, Medical, Powered | LGX | Class 1 | General, Plastic Surgery | No | 2009-04-17 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2006-01-11 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2017-02-20 |
Proprietary Names
Evolution5HD
Ibis Epilator Needle
Blend ST 250
Evolution 7HD Sequential
Evolution XHD
Evolution ST350
Soli-Lite LG2
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
Serenity SBF-4c
Laguna Nigel 2011
Newstream massage table 4 Cushions
Nevada Electric 4C/32"
NewStream Serenity Table
Laguna Mist 29"
Nevada Electric Cabinet
Escape
Laguna Mist 32"
Nevada Electric 4C/30"
Laguna Sand SBF-4C
Laguna Sand 30"
Elantra
Etna
Spa One
Laguna Edge (2M)
PR Cell
Soma Bora Bora (26" x 72")
Soma Borneo 30" (3 cushions)
Soma Maldives Table (29" x 77")
Q-switched Nd:YAG Laser System
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device