# Silhouet-Tone Corporation · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 2185 Michelin St , Laval, Quebec CANADA _(verified: appears in the quote below)_
- **Date published:** 09/20/2013 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **Product:** Lipomax RF | Lumicell Wave | Lipomax RF | Lumicell Wave | Lumicell Wave | Lipomax RF | Lipomax RF | Lumicell Wave | Lumicell Wave | Lumicell Wave | Lipomax RF _(verified: each item appears in the quote below)_
- **FDA notes:** clas II | class II | class II | class II | class II | class II | class II | class II | class II | Class II | Class II _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).