Reference Source

GUAUNGZHOU KONMISON ELECTRONIC TECHNOLOGY CO., LIMITED · 89-08 · CHINA

For GUAUNGZHOU KONMISON ELECTRONIC TECHNOLOGY CO., LIMITED · 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 OXYGENATING INFUSION | 5-in-1 Dermal Reset Beauty Optimization | 5-in-1 Dermal Reset Beauty Optimization | LIGHT FREQUENCY THERAPY | 5-in-1 Dermal Reset Beauty Optimization | LIGHT FREQUENCY THERAPY | RADIOFREQUENCY STIMULATION | 5-in-1 Dermal Reset Beauty Optimization | 5-in-1 Dermal Reset Beauty Optimization | DERMAL NEEDLING ENHANCER | 5-in-1 Dermal Reset Beauty Optimization; product code is 73 P - - CM Portable liquid oxygen unit stand | 79 G - - FE Brush, Dermabrasion | 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - LP Over-the-counter powered red/blue light based laser for acne | 79 O - - LP Over-the-counter powered red/blue light based laser for acne | 79 P - - AY Over-the-counter radiofrequency coagulation device for wrinkle reduction | 79 P - - AY Over-the-counter radiofrequency coagulation device for wrinkle reduction | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 89 I - - SA Massager, Therapeutic, Electric; date published is 03/27/2023; address is Room 205 , Building No.2, Rich Plaza, No.7, Nanzhuang Road,Yongping Street, Baiyun District, Guangzhou City , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

Firm
GUAUNGZHOU KONMISON ELECTRONIC TECHNOLOGY CO., LIMITED 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
Room 205 , Building No.2, Rich Plaza, No.7, Nanzhuang Road,Yongping Street, Baiyun District, Guangzhou City , Guangzhou, Guangdong CHINA verified
Date published
03/27/2023 verified
Product code
73 P - - CM Portable liquid oxygen unit stand | 79 G - - FE Brush, Dermabrasion | 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - LP Over-the-counter powered red/blue light based laser for acne | 79 O - - LP Over-the-counter powered red/blue light based laser for acne | 79 P - - AY Over-the-counter radiofrequency coagulation device for wrinkle reduction | 79 P - - AY Over-the-counter radiofrequency coagulation device for wrinkle reduction | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 89 I - - SA Massager, Therapeutic, Electric each item verified
Product
OXYGENATING INFUSION | 5-in-1 Dermal Reset Beauty Optimization | 5-in-1 Dermal Reset Beauty Optimization | LIGHT FREQUENCY THERAPY | 5-in-1 Dermal Reset Beauty Optimization | LIGHT FREQUENCY THERAPY | RADIOFREQUENCY STIMULATION | 5-in-1 Dermal Reset Beauty Optimization | 5-in-1 Dermal Reset Beauty Optimization | DERMAL NEEDLING ENHANCER | 5-in-1 Dermal Reset Beauty Optimization each item verified
FDA notes
Vibrational Exfoliator handpiece is not subject to DWEP under this import alert | Vibrational Exfoliator handpiece is not subject to DWEP under this import alert | Vibrational Exfoliator handpiece is not subject to DWEP under this import alert | Vibrational Exfoliator handpiece is not subject to DWEP under this import alert | Vibrational Exfoliator handpiece is not subject to DWEP under this import alert | Vibrational Exfoliator handpiece is not subject to DWEP under this import alert | Vibrational Exfoliator handpiece is not subject to DWEP under this import alert | Vibrational Exfoliator handpiece is not subject to DWEP under this import alert | Vibrational Exfoliator handpiece is not subject to DWEP under this import alert | Vibrational Exfoliator handpiece is not subject to DWEP under this import alert | Vibrational Exfoliator handpiece is not subject to DWEP under this import alert 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

GUAUNGZHOU KONMISON ELECTRONIC TECHNOLOGY CO., LIMITED Date Published : 03/27/2023 Room 205 , Building No.2, Rich Plaza, No.7, Nanzhuang Road,Yongping Street, Baiyun District, Guangzhou City , Guangzhou, Guangdong CHINA 73 P - - CM Portable liquid oxygen unit stand Date Published: 03/27/2023 Desc: OXYGENATING INFUSION Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert 79 G - - FE Brush, Dermabrasion Date Published: 03/27/2023 Desc: 5-in-1 Dermal Reset Beauty Optimization Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 03/27/2023 Desc: 5-in-1 Dermal Reset Beauty Optimization Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 03/27/2023 Desc: LIGHT FREQUENCY THERAPY Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert 79 O - - LP Over-the-counter powered red/blue light based laser for acne Date Published: 03/27/2023 Desc: 5-in-1 Dermal Reset Beauty Optimization Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert 79 O - - LP Over-the-counter powered red/blue light based laser for acne Date Published: 03/27/2023 Desc: LIGHT FREQUENCY THERAPY Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert 79 P - - AY Over-the-counter radiofrequency coagulation device for wrinkle reduction Date Published: 03/27/2023 Desc: RADIOFREQUENCY STIMULATION Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert 79 P - - AY Over-the-counter radiofrequency coagulation device for wrinkle reduction Date Published: 03/27/2023 Desc: 5-in-1 Dermal Reset Beauty Optimization Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert 79 Q - - AI Powered microneedle device Date Published: 03/27/2023 Desc: 5-in-1 Dermal Reset Beauty Optimization Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert 79 Q - - AI Powered microneedle device Date Published: 03/27/2023 Desc: DERMAL NEEDLING ENHANCER Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert 89 I - - SA Massager, Therapeutic, Electric Date Published: 03/27/2023 Desc: 5-in-1 Dermal Reset Beauty Optimization Notes: Vibrational Exfoliator handpiece is not subject to DWEP under this import alert

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

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