Wuhan Lotuxs Technology Co., Ltd. · 89-08 · CHINA
For Wuhan Lotuxs Technology Co., Ltd. · 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html