KOMENT SAS · 89-08 · COLOMBIA
For KOMENT SAS, import alert is 89-08; country is COLOMBIA; 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 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html