Dongguan City Meizhi Wiring Co., LTD. · 89-08 · CHINA
For Dongguan City Meizhi Wiring 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 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 2026-09-30.
- 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
What the source says
Dongguan City Meizhi Wiring Co., LTD. Date Published : 08/08/2011 Mange Zone, Dongguan City, Tiantoujiao , Qiaotou Town , Dongguan, 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 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html