Wuhan Lotuxs Technology Co., Ltd. · 89-08 · CHINA
For Wuhan Lotuxs 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 Pink Luminous Breast | Pink Luminous Breast | Pink Luminous Breast | Pink Luminous Breast | Pink Luminous Breast; product code is 79 O - - HT Light based over-the-counter hair removal | 79 P - - KT Laser for disruption of adipocyte cells for aesthetic use | 80 F - - LG Cleaner, Ultrasonic, Medical Instrument | 89 I - - LY Lamp, infrared, therapeutic heating | 90 L - - EK Transilluminator (Diaphanoscope); date published is 09/02/2020; address is 5F, E2 BUILDING, NO.999 GAOXIN AVENUE, , FUTURE CITY, , EAST LAKE HIGH-TECH DEVELOPMENT ZONE , Wuhan, Hubei CHINA, verified against its source on 2026-09-30.
- Firm
- Wuhan Lotuxs 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
- 5F, E2 BUILDING, NO.999 GAOXIN AVENUE, , FUTURE CITY, , EAST LAKE HIGH-TECH DEVELOPMENT ZONE , Wuhan, Hubei CHINA verified
- Date published
- 09/02/2020 verified
- Product code
- 79 O - - HT Light based over-the-counter hair removal | 79 P - - KT Laser for disruption of adipocyte cells for aesthetic use | 80 F - - LG Cleaner, Ultrasonic, Medical Instrument | 89 I - - LY Lamp, infrared, therapeutic heating | 90 L - - EK Transilluminator (Diaphanoscope) each item verified
- Product
- Pink Luminous Breast | Pink Luminous Breast | Pink Luminous Breast | Pink Luminous Breast | Pink Luminous Breast each item verified
- FDA notes
- Class III device, requires 510(k), or de novo application | Class III device, requires 510(k), or de novo application | Class III device, requires 510(k), or de novo application | Class III device, requires 510(k), or de novo application | Class III device, requires 510(k), or de novo application each item verified
What the source says
Wuhan Lotuxs Technology Co., Ltd. Date Published : 09/02/2020 5F, E2 BUILDING, NO.999 GAOXIN AVENUE, , FUTURE CITY, , EAST LAKE HIGH-TECH DEVELOPMENT ZONE , Wuhan, Hubei 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 O - - HT Light based over-the-counter hair removal Date Published: 09/02/2020 Desc: Pink Luminous Breast Notes: Class III device, requires 510(k), or de novo application 79 P - - KT Laser for disruption of adipocyte cells for aesthetic use Date Published: 09/02/2020 Desc: Pink Luminous Breast Notes: Class III device, requires 510(k), or de novo application 80 F - - LG Cleaner, Ultrasonic, Medical Instrument Date Published: 09/02/2020 Desc: Pink Luminous Breast Notes: Class III device, requires 510(k), or de novo application 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 09/02/2020 Desc: Pink Luminous Breast Notes: Class III device, requires 510(k), or de novo application 90 L - - EK Transilluminator (Diaphanoscope) Date Published: 09/02/2020 Desc: Pink Luminous Breast Notes: Class III device, requires 510(k), or de novo application
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html