Reference Source

Sunlive Technology Co Ltd · 89-08 · CHINA

For Sunlive Technology 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 Capillus 272 Laser Hair Cap | Capillus 272 Laser Hair Cap; product code is 79 O - - AP laser, comb, hair | 95 R - - DW General Purpose Laser Products, Non-Medical; date published is 10/24/2013; address is Building C Taihua Junyi Park Xinhu , Road Bao'an District , Shenzhyen, Guangdong CHINA, verified against its source on 2026-09-16.

Firm
Sunlive Technology 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
Building C Taihua Junyi Park Xinhu , Road Bao'an District , Shenzhyen, Guangdong CHINA verified
Date published
10/24/2013 verified
Product code
79 O - - AP laser, comb, hair | 95 R - - DW General Purpose Laser Products, Non-Medical each item verified
Product
Capillus 272 Laser Hair Cap | Capillus 272 Laser Hair Cap each item verified
FDA notes
Class III | Class III 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

Sunlive Technology Co Ltd Date Published : 10/24/2013 Building C Taihua Junyi Park Xinhu , Road Bao'an District , Shenzhyen, Guangdong CHINA 79 O - - AP laser, comb, hair Date Published: 10/23/2014 Desc: Capillus 272 Laser Hair Cap Notes: Class III 95 R - - DW General Purpose Laser Products, Non-Medical Date Published: 10/23/2014 Desc: Capillus 272 Laser Hair Cap Notes: Class III

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

Source

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