Reference Source

Guangzhou Inkue Technology Co Ltd · 89-08 · CHINA

For Guangzhou Inkue 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 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 2026-09-30.

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

— 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 - - 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

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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