Reference Source

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

For Wei Cia Ma Kang Co Ltd, 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 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 2026-09-30.

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

— 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: 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

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

Source

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