Reference Source

Wei Cia Ma Kang Co Ltd · 89-08 · CHINA

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
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
Wang Yu Jie , Wei Cia, CHINA verified
Date published
01/17/2014 verified
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 each item verified
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 each item verified
FDA notes
Class II | 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

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

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

Source

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