# Mychway Co. Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Mychway Co. Ltd. · 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 | Laser Lipolysis Device; product code is 79 G - - FE Brush, Dermabrasion | 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 05/05/2013; address is Pengdu Building Room 1701 , 126 Nanguang Road; Guangdong , Shenzhen, CHINA, verified against its source on 2026-09-16.

- **Firm:** Mychway Co. Ltd. _(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:** Pengdu Building Room 1701 , 126 Nanguang Road; Guangdong , Shenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 05/05/2013 _(verified: appears in the quote below)_
- **Product code:** 79 G - - FE Brush, Dermabrasion | 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 _(verified: each item appears in the quote below)_
- **Product:** Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device _(verified: each item appears in the quote below)_
- **FDA notes:** class II | class II | class II | Class II | class II _(verified: each item appears in the quote below)_

## What the source says

> Mychway Co. Ltd. Date Published : 05/05/2013 Pengdu Building Room 1701 , 126 Nanguang Road; Guangdong , Shenzhen, CHINA 79 G - - FE Brush, Dermabrasion Date Published: 05/05/2013 Desc: Laser Lipolysis Device Notes: class II 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: 05/05/2013 Desc: Laser Lipolysis Device Notes: class II 79 O - - RK Laser assisted lipolysis Date Published: 05/05/2013 Desc: Laser Lipolysis Device Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 05/05/2013 Desc: Laser Lipolysis Device 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/).