Reference Source

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

For Zhongshan Bisen Plastic Electronic Products Co., Ltd., import alert is 89-08; country is CHINA; 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)"; product is Jupiter Light Therapy Device | REG 3 Pro Touch | Vega 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 2026-09-30.

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
Jupiter Light Therapy Device | REG 3 Pro Touch | Vega 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

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code and Product

79 O - - HS Light Based over the counter wrinkle reduction Date Published: 08/09/2021 Desc: Jupiter Light Therapy Device Notes: 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 - - 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:

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

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