KOMENT SAS · 89-08 · COLOMBIA
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
- 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
- Address
- Cra 31w #71-119 Parque , Bucaeamanga, COLOMBIA verified
- Date published
- 12/01/2025 verified
- Product code
- 89 I - - SA Massager, Therapeutic, Electric | 97 R - - AL Massager, Ultrasonic Non-Medical Devices each item verified
- Product
- DELUXE PRO BODY SCULPTING DEVICE | DELUXE PRO BODY SCULPTING DEVICE each item verified
- FDA notes
- Class I | Class I each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.