VIS (Shanghai) Technology Co., Ltd. · 89-08 · CHINA
For VIS (Shanghai) Technology 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 ESPADA 2 plus (ACNE CLEARING BLUE LIGHT PEN); product code is 79 O - - LP Over-the-counter powered red/blue light based laser for acne; date published is 06/05/2024; address is Tinglin Town , No. 58 Linsheng Road; Jinshan , Shanghai, Shanghai CHINA, verified against its source on 2026-09-30.
- Firm
- VIS (Shanghai) Technology 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
- Tinglin Town , No. 58 Linsheng Road; Jinshan , Shanghai, Shanghai CHINA verified
- Date published
- 06/05/2024 verified
- Product code
- 79 O - - LP Over-the-counter powered red/blue light based laser for acne verified
- Product
- ESPADA 2 plus (ACNE CLEARING BLUE LIGHT PEN) verified
What the source says
VIS (Shanghai) Technology Co., Ltd. Date Published : 06/05/2024 Tinglin Town , No. 58 Linsheng Road; Jinshan , Shanghai, Shanghai CHINA
— accessdata.fda.gov, retrieved 2026-09-15
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 - - LP Over-the-counter powered red/blue light based laser for acne Date Published: 06/05/2024 Desc: ESPADA 2 plus (ACNE CLEARING BLUE LIGHT PEN)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html