Les Products Co Ltd · 89-08 · CHINA
For Les Products Co Ltd, import alert is 89-08; country is CHINA; 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 Bt-Micro Dermabrasion Unit | Bt-Micro Dermabrasion Unit; product code is 89 E - - GJ Device, Iontophoresis, Other Uses | 89 K - - TB Device, Iontophoresis, Specific Uses; date published is 08/21/2012; address is Room NO.804 , Guanlida Buildingqianjin Rd; Baoan , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- Les Products Co Ltd 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
- CHINA verified
- Address
- Room NO.804 , Guanlida Buildingqianjin Rd; Baoan , Shenzhen, Guangdong CHINA verified
- Date published
- 08/21/2012 verified
- Product code
- 89 E - - GJ Device, Iontophoresis, Other Uses | 89 K - - TB Device, Iontophoresis, Specific Uses each item verified
- Product
- Bt-Micro Dermabrasion Unit | Bt-Micro Dermabrasion Unit each item verified
- FDA notes
- Class II | class II each item verified
What the source says
Les Products Co Ltd Date Published : 08/21/2012 Room NO.804 , Guanlida Buildingqianjin Rd; Baoan , Shenzhen, Guangdong CHINA
— 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 E - - GJ Device, Iontophoresis, Other Uses Date Published: 08/21/2012 Desc: Bt-Micro Dermabrasion Unit Notes: Class II 89 K - - TB Device, Iontophoresis, Specific Uses Date Published: 08/21/2012 Desc: Bt-Micro Dermabrasion Unit Notes: class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html