# SHENZHEN RONG SHUO TECHNOLOGY · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For SHENZHEN RONG SHUO TECHNOLOGY · 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 Diode Laser Hair Removal Machine | Diode Laser Hair Removal Machine; product code is 79 G - - EX Powered laser surgical instruments | 95 R - - HH LED, General Purpose Illumination, General Optical Products, Non-Medical; date published is 09/25/2024; address is Room 105 , Building C, Icc Industria,Hangcheng Street, Bao 'An District , Shenzhen, CHINA, verified against its source on 2026-09-16.

- **Firm:** SHENZHEN RONG SHUO TECHNOLOGY _(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:** Room 105 , Building C, Icc Industria,Hangcheng Street, Bao 'An District , Shenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 09/25/2024 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EX Powered laser surgical instruments | 95 R - - HH LED, General Purpose Illumination, General Optical Products, Non-Medical _(verified: each item appears in the quote below)_
- **Product:** Diode Laser Hair Removal Machine | Diode Laser Hair Removal Machine _(verified: each item appears in the quote below)_

## What the source says

> SHENZHEN RONG SHUO TECHNOLOGY Date Published : 09/25/2024 Room 105 , Building C, Icc Industria,Hangcheng Street, Bao 'An District , Shenzhen, CHINA 79 G - - EX Powered laser surgical instruments Date Published: 09/25/2024 Desc: Diode Laser Hair Removal Machine 95 R - - HH LED, General Purpose Illumination, General Optical Products, Non-Medical Date Published: 09/25/2024 Desc: Diode Laser Hair Removal Machine

## 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/).