# KOMENT SAS · 89-08 · COLOMBIA — FDA import alert red lists: firms subject to detention without physical examination

For KOMENT SAS · 89-08 · COLOMBIA, 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 COLOMBIA; product is DELUXE PRO BODY SCULPTING DEVICE | DELUXE PRO BODY SCULPTING DEVICE; product code is 89 I - - SA Massager, Therapeutic, Electric | 97 R - - AL Massager, Ultrasonic Non-Medical Devices; date published is 12/01/2025; address is Cra 31w #71-119 Parque , Bucaeamanga, COLOMBIA, verified against its source on 2026-09-16.

- **Firm:** KOMENT SAS _(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:** COLOMBIA _(verified: appears in the quote below)_
- **Address:** Cra 31w #71-119 Parque , Bucaeamanga, COLOMBIA _(verified: appears in the quote below)_
- **Date published:** 12/01/2025 _(verified: appears in the quote below)_
- **Product code:** 89 I - - SA Massager, Therapeutic, Electric | 97 R - - AL Massager, Ultrasonic Non-Medical Devices _(verified: each item appears in the quote below)_
- **Product:** DELUXE PRO BODY SCULPTING DEVICE | DELUXE PRO BODY SCULPTING DEVICE _(verified: each item appears in the quote below)_
- **FDA notes:** Class I | Class I _(verified: each item appears in the quote below)_

## What the source says

> KOMENT SAS Date Published : 12/01/2025 Cra 31w #71-119 Parque , Bucaeamanga, COLOMBIA 89 I - - SA Massager, Therapeutic, Electric Date Published: 12/01/2025 Desc: DELUXE PRO BODY SCULPTING DEVICE Notes: Class I 97 R - - AL Massager, Ultrasonic Non-Medical Devices Date Published: 12/01/2025 Desc: DELUXE PRO BODY SCULPTING DEVICE Notes: Class I

## 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/).