Silhouet-Tone Corporation · 89-08 · CANADA
For Silhouet-Tone Corporation, import alert is 89-08; country is CANADA; 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)"; product is Lipomax RF | Lumicell Wave | Lipomax RF | Lumicell Wave | Lipomax RF | Lumicell Wave | Lipomax RF | Lumicell Wave | Lumicell Wave | Lipomax RF | Lumicell Wave; 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 2026-09-30.
- 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 | Lipomax RF | Lumicell Wave | Lipomax RF | Lumicell Wave | Lumicell Wave | Lipomax RF | Lumicell Wave 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
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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: Lipomax RF Notes: class II 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 09/20/2013 Desc: Lumicell Wave 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: Lipomax RF Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 09/20/2013 Desc: Lumicell Wave Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html