# Wei Cia Ma Kang Co Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Wei Cia Ma Kang 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 Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles | Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles | Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles; product code is 79 G - - EX Powered laser surgical instruments | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 O - - HS Light Based over the counter wrinkle reduction; date published is 01/17/2014; address is Wang Yu Jie , Wei Cia, CHINA, verified against its source on 2026-09-16.

- **Firm:** Wei Cia Ma Kang 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:** Wang Yu Jie , Wei Cia, CHINA _(verified: appears in the quote below)_
- **Date published:** 01/17/2014 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EX Powered laser surgical instruments | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 O - - HS Light Based over the counter wrinkle reduction _(verified: each item appears in the quote below)_
- **Product:** Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles | Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles | Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | class II | class II _(verified: each item appears in the quote below)_

## What the source says

> Wei Cia Ma Kang Co Ltd Date Published : 01/17/2014 Wang Yu Jie , Wei Cia, CHINA 79 G - - EX Powered laser surgical instruments Date Published: 01/17/2014 Desc: Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles Notes: Class II 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles Notes: class II 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 01/17/2014 Desc: Micro Needle Skin Roller Deep Facial Washing Machine Micro Needles 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/).