VIS (Shanghai) Technology Co., Ltd. · 89-08 · CHINA
For VIS (Shanghai) Technology 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 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 2026-09-16.
- 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 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)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.