# SHENZHEN MYCHWAY TECHNOLOGY CO L · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** F 4 , 406 Zhongxin Industr , Shenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 05/18/2015 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EX Powered laser surgical instruments | 79 O - - RK Laser assisted lipolysis _(verified: each item appears in the quote below)_
- **Product:** Lipolysis Laser | Lipolysis Laser _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).