Guangzhou Beco Electronic · 89-08 · CHINA
For Guangzhou Beco Electronic, 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 Laser Lipolysis device | Laser Lipolysis device | Laser Lipolysis device | Laser Lipolysis device; product code is 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 O - - RK Laser assisted lipolysis | 89 I - - SA Massager, Therapeutic, Electric; date published is 10/30/2013; address is 113 Huadi Avenue South , Li Wan District , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- Guangzhou Beco Electronic 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
- 113 Huadi Avenue South , Li Wan District , Guangzhou, Guangdong CHINA verified
- Date published
- 10/30/2013 verified
- Product code
- 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 O - - RK Laser assisted lipolysis | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Laser Lipolysis device | Laser Lipolysis device | Laser Lipolysis device | Laser Lipolysis device each item verified
- FDA notes
- class II | class II | Class II | class II each item verified
What the source says
Guangzhou Beco Electronic Date Published : 10/30/2013 113 Huadi Avenue South , Li Wan District , Guangzhou, 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
79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: Laser Lipolysis device Notes: class II 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager Date Published: 10/30/2013 Desc: Laser Lipolysis device Notes: class II 79 O - - RK Laser assisted lipolysis Date Published: 10/30/2013 Desc: Laser Lipolysis device Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 10/30/2013 Desc: Laser Lipolysis device 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