Stareast Beauty & Health Mfg · 89-08 · CHINA
For Stareast Beauty & Health Mfg, 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 Intense Pulsed Light (IPL) System (Non-Laser) | Intense Pulsed Light (IPL) System (Non-Laser); product code is 79 G - - EX Powered laser surgical instruments | 79 O - - NF Powered light based non-laser surgical instrument with thermal effect; date published is 08/01/2011; address is No 9 Bixi Road Daliang , Guangdong, CHINA, verified against its source on 2026-09-30.
- Firm
- Stareast Beauty & Health Mfg 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
- No 9 Bixi Road Daliang , Guangdong, CHINA verified
- Date published
- 08/01/2011 verified
- Product code
- 79 G - - EX Powered laser surgical instruments | 79 O - - NF Powered light based non-laser surgical instrument with thermal effect each item verified
- Product
- Intense Pulsed Light (IPL) System (Non-Laser) | Intense Pulsed Light (IPL) System (Non-Laser) each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Stareast Beauty & Health Mfg Date Published : 08/01/2011 No 9 Bixi Road Daliang , 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 G - - EX Powered laser surgical instruments Date Published: 08/08/2011 Desc: Intense Pulsed Light (IPL) System (Non-Laser) Notes: Class II 79 O - - NF Powered light based non-laser surgical instrument with thermal effect Date Published: 08/01/2011 Desc: Intense Pulsed Light (IPL) System (Non-Laser) 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