Reference Source

SHENZHEN MYCHWAY TECHNOLOGY CO L · 89-08 · CHINA

For SHENZHEN MYCHWAY TECHNOLOGY CO L · 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 Lipolysis Laser | Lipolysis Laser; product code is 79 G - - EX Powered laser surgical instruments | 79 O - - RK Laser assisted lipolysis; date published is 05/18/2015; address is F 4 , 406 Zhongxin Industr , Shenzhen, CHINA, verified against its source on 2026-09-16.

Firm
SHENZHEN MYCHWAY TECHNOLOGY CO L 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
F 4 , 406 Zhongxin Industr , Shenzhen, CHINA verified
Date published
05/18/2015 verified
Product code
79 G - - EX Powered laser surgical instruments | 79 O - - RK Laser assisted lipolysis each item verified
Product
Lipolysis Laser | Lipolysis Laser each item verified
FDA notes
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

SHENZHEN MYCHWAY TECHNOLOGY CO L Date Published : 05/18/2015 F 4 , 406 Zhongxin Industr , Shenzhen, CHINA 79 G - - EX Powered laser surgical instruments Date Published: 05/18/2015 Desc: Lipolysis Laser Notes: Class II 79 O - - RK Laser assisted lipolysis Date Published: 05/18/2015 Desc: Lipolysis Laser Notes: Class II

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

Source

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