Reference Source

Guangzhou Inkue Technology Co Ltd · 89-08 · CHINA

For Guangzhou Inkue 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 Skin Scrubber Beauty Machine | Skin Scrubber Beauty Machine | Skin Scrubber Beauty Machine; product code is 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption; date published is 11/01/2012; address is Floor 3 Tower A, Fengsheng Industry , Guangzhou, CHINA, verified against its source on 2026-09-16.

Firm
Guangzhou Inkue 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
Floor 3 Tower A, Fengsheng Industry , Guangzhou, CHINA verified
Date published
11/01/2012 verified
Product code
79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption each item verified
Product
Skin Scrubber Beauty Machine | Skin Scrubber Beauty Machine | Skin Scrubber Beauty Machine each item verified
FDA notes
class II | 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

Guangzhou Inkue Technology Co Ltd Date Published : 11/01/2012 Floor 3 Tower A, Fengsheng Industry , Guangzhou, CHINA 79 G - - ED Brush, Dermabrasion, Manual Date Published: 11/01/2012 Desc: Skin Scrubber Beauty Machine Notes: class II 79 G - - FE Brush, Dermabrasion Date Published: 11/01/2012 Desc: Skin Scrubber Beauty Machine Notes: class II 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 11/01/2012 Desc: Skin Scrubber Beauty Machine Notes: Class II

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

Source

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