# VIS (Shanghai) Technology Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** Tinglin Town , No. 58 Linsheng Road; Jinshan , Shanghai, Shanghai CHINA _(verified: appears in the quote below)_
- **Date published:** 06/05/2024 _(verified: appears in the quote below)_
- **Product code:** 79 O - - LP Over-the-counter powered red/blue light based laser for acne _(verified: appears in the quote below)_
- **Product:** ESPADA 2 plus (ACNE CLEARING BLUE LIGHT PEN) _(verified: appears in the quote below)_

## 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)

## 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/).