Reference Source

Guangzhou Beco Electronic · 89-08 · CHINA

For Guangzhou Beco Electronic · 89-08 · CHINA, 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 CHINA; 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Guangzhou Beco Electronic Date Published : 10/30/2013 113 Huadi Avenue South , Li Wan District , Guangzhou, Guangdong CHINA 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

accessdata.fda.gov, retrieved 2026-09-15

Source

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