Reference Source

Balon Beauty Factory · 89-08 · CHINA

For Balon Beauty Factory · 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 code is 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 89 I - - SA Massager, Therapeutic, Electric | 97 R - - AF Cleaner, Ultrasonic Non-Medical Devices; date published is 12/14/2011; address is 138 Area B Industrial Zone 3 , Guangzhou, CHINA, verified against its source on 2026-09-16.

Firm
Balon Beauty Factory 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
138 Area B Industrial Zone 3 , Guangzhou, CHINA verified
Date published
12/14/2011 verified
Product code
79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 89 I - - SA Massager, Therapeutic, Electric | 97 R - - AF Cleaner, Ultrasonic Non-Medical Devices each item verified
FDA notes
Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon | Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon | Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon | Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon | Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon & Ultrasonic) ; 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

Balon Beauty Factory Date Published : 12/14/2011 138 Area B Industrial Zone 3 , Guangzhou, CHINA 79 G - - ED Brush, Dermabrasion, Manual Date Published: 12/14/2011 Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon 79 G - - FE Brush, Dermabrasion Date Published: 12/14/2011 Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon 89 I - - SA Massager, Therapeutic, Electric Date Published: 12/14/2011 Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon 97 R - - AF Cleaner, Ultrasonic Non-Medical Devices Date Published: 12/14/2011 Notes: Various Dermabrasion Devices (Includes Crystal Microdermabrasion Duo Peel; Portable Facial Skin Scrubber; Diamond Dermabrasion-Galvanic; Scrubber; Photon & Ultrasonic) ;

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

Source

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