Sunlive Technology Co Ltd · 89-08 · CHINA
For Sunlive Technology 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 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 2026-09-30.
- 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
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
— 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 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html