# Zhongshan Bisen Plastic Electronic Products Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Zhongshan Bisen Plastic Electronic Products 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 REG 3 Pro Touch | Vega Light Therapy Device | Jupiter Light Therapy Device | Jupiter Light Therapy Device | Neptune Light Therapy Device; product code is 79 O - - HS Light Based over the counter wrinkle reduction | 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; date published is 08/09/2021; address is 2nd Fl, A bldg, No. 32 Jianye Rd , Torch Development Zone , Zhongshan, CHINA, verified against its source on 2026-09-16.

- **Firm:** Zhongshan Bisen Plastic Electronic Products 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:** 2nd Fl, A bldg, No. 32 Jianye Rd , Torch Development Zone , Zhongshan, CHINA _(verified: appears in the quote below)_
- **Date published:** 08/09/2021 _(verified: appears in the quote below)_
- **Product code:** 79 O - - HS Light Based over the counter wrinkle reduction | 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 _(verified: each item appears in the quote below)_
- **Product:** REG 3 Pro Touch | Vega Light Therapy Device | Jupiter Light Therapy Device | Jupiter Light Therapy Device | Neptune Light Therapy Device _(verified: each item appears in the quote below)_

## What the source says

> Zhongshan Bisen Plastic Electronic Products Co., Ltd. Date Published : 08/09/2021 2nd Fl, A bldg, No. 32 Jianye Rd , Torch Development Zone , Zhongshan, CHINA 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 01/17/2025 Desc: REG 3 Pro Touch Notes: 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 08/09/2021 Desc: Vega Light Therapy Device Notes: 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 08/09/2021 Desc: Jupiter Light Therapy Device Notes: 79 O - - LP Over-the-counter powered red/blue light based laser for acne Date Published: 08/09/2021 Desc: Jupiter Light Therapy Device Notes: 79 O - - LP Over-the-counter powered red/blue light based laser for acne Date Published: 08/09/2021 Desc: Neptune Light Therapy Device Notes:

## 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/).