Reference Source

SHENZHEN MYCHWAY TECHNOLOGY CO L · 89-08 · CHINA

For SHENZHEN MYCHWAY TECHNOLOGY CO L, 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 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 2026-09-30.

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

— 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 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

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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