Silhouet-Tone Corporation · 89-08 · CANADA
For Silhouet-Tone Corporation · 89-08 · CANADA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CANADA; product is Lipomax RF | Lumicell Wave | Lipomax RF | Lumicell Wave | Lumicell Wave | Lipomax RF | Lipomax RF | Lumicell Wave | Lumicell Wave | Lumicell Wave | Lipomax RF; product code is 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - RO Vibrator, Therapeutic | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric; date published is 09/20/2013; address is 2185 Michelin St , Laval, Quebec CANADA, verified against its source on 2026-09-16.
- Firm
- Silhouet-Tone Corporation verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CANADA verified
- Address
- 2185 Michelin St , Laval, Quebec CANADA verified
- Date published
- 09/20/2013 verified
- Product code
- 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat | 89 I - - RO Vibrator, Therapeutic | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Lipomax RF | Lumicell Wave | Lipomax RF | Lumicell Wave | Lumicell Wave | Lipomax RF | Lipomax RF | Lumicell Wave | Lumicell Wave | Lumicell Wave | Lipomax RF each item verified
- FDA notes
- clas II | class II | class II | class II | class II | class II | class II | class II | class II | Class II | Class II each item verified
What the source says
Silhouet-Tone Corporation Date Published : 09/20/2013 2185 Michelin St , Laval, Quebec CANADA 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 09/20/2013 Desc: Lipomax RF Notes: clas II 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 09/20/2013 Desc: Lumicell Wave Notes: class II 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 09/20/2013 Desc: Lipomax RF Notes: class II 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 09/20/2013 Desc: Lumicell Wave Notes: class II 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 09/20/2013 Desc: Lumicell Wave Notes: class II 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 09/20/2013 Desc: Lipomax RF Notes: class II 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat Date Published: 09/20/2013 Desc: Lipomax RF Notes: class II 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat Date Published: 09/20/2013 Desc: Lumicell Wave Notes: class II 89 I - - RO Vibrator, Therapeutic Date Published: 09/20/2013 Desc: Lumicell Wave Notes: class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 09/20/2013 Desc: Lumicell Wave Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 09/20/2013 Desc: Lipomax RF Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html