Reference Source

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

For GUAUNGZHOU KONMISON ELECTRONIC TECHNOLOGY CO., LIMITED, 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 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 | 5-in-1 Dermal Reset Beauty Optimization | RADIOFREQUENCY STIMULATION | 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 2026-09-30.

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 | 5-in-1 Dermal Reset Beauty Optimization | RADIOFREQUENCY STIMULATION | 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

— accessdata.fda.gov, retrieved 2026-09-22

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

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: 5-in-1 Dermal Reset Beauty Optimization 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 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

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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