Reference Source

Dongguan City Meizhi Wiring Co., LTD. · 89-08 · CHINA

For Dongguan City Meizhi Wiring 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 Color Ray Beauty Light Therapy Device | Color Ray Beauty Light Therapy Device; product code is 79 N - - ZY Light, lymphadema reduction, low energy | 79 O - - LP Over-the-counter powered red/blue light based laser for acne; date published is 08/08/2011; address is Mange Zone, Dongguan City, Tiantoujiao , Qiaotou Town , Dongguan, CHINA, verified against its source on 2026-09-16.

Firm
Dongguan City Meizhi Wiring 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
Mange Zone, Dongguan City, Tiantoujiao , Qiaotou Town , Dongguan, CHINA verified
Date published
08/08/2011 verified
Product code
79 N - - ZY Light, lymphadema reduction, low energy | 79 O - - LP Over-the-counter powered red/blue light based laser for acne each item verified
Product
Color Ray Beauty Light Therapy Device | Color Ray Beauty Light Therapy Device each item verified
FDA notes
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

Dongguan City Meizhi Wiring Co., LTD. Date Published : 08/08/2011 Mange Zone, Dongguan City, Tiantoujiao , Qiaotou Town , Dongguan, CHINA 79 N - - ZY Light, lymphadema reduction, low energy Date Published: 11/08/2018 Desc: Color Ray Beauty Light Therapy Device Notes: Class II 79 O - - LP Over-the-counter powered red/blue light based laser for acne Date Published: 08/08/2011 Desc: Color Ray Beauty Light Therapy Device Notes: Class II

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

Source

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