Reference Source

Zhongshan Bisen Plastic Electronic Products Co., Ltd. · 89-08 · CHINA

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
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
2nd Fl, A bldg, No. 32 Jianye Rd , Torch Development Zone , Zhongshan, CHINA verified
Date published
08/09/2021 verified
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 each item verified
Product
REG 3 Pro Touch | Vega Light Therapy Device | Jupiter Light Therapy Device | Jupiter Light Therapy Device | Neptune Light Therapy Device each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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:

accessdata.fda.gov, retrieved 2026-09-15

Source

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