Reference Source

Stareast Beauty & Health Mfg · 89-08 · CHINA

For Stareast Beauty & Health Mfg · 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 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Stareast Beauty & Health Mfg Date Published : 08/01/2011 No 9 Bixi Road Daliang , Guangdong, CHINA 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

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

Source

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