# Wuhan Lotuxs Technology Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 5F, E2 BUILDING, NO.999 GAOXIN AVENUE, , FUTURE CITY, , EAST LAKE HIGH-TECH DEVELOPMENT ZONE , Wuhan, Hubei CHINA _(verified: appears in the quote below)_
- **Date published:** 09/02/2020 _(verified: appears in the quote below)_
- **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) _(verified: each item appears in the quote below)_
- **Product:** Pink Luminous Breast | Pink Luminous Breast | Pink Luminous Breast | Pink Luminous Breast | Pink Luminous Breast _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).