# BNB MEDICAL CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For BNB MEDICAL CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is BND Laser Hair Remover Models W-808 CW-808 (Epila and Venus Laser Hair Removal devices) | BND Laser Hair Remover Models W-808 CW-808 (Epila and Venus Laser Hair Removal devices); product code is 79 K - - CX Epilator, High Frequency, Tweezer-Type | 86 L - - ZS Laser, System, Excimer; date published is 08/22/2011; address is #404 Hyundai Hyel , 779-11 Jayang-Dong, Gwangjin-Gu , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** BNB MEDICAL 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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** #404 Hyundai Hyel , 779-11 Jayang-Dong, Gwangjin-Gu , Seoul, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 08/22/2011 _(verified: appears in the quote below)_
- **Product code:** 79 K - - CX Epilator, High Frequency, Tweezer-Type | 86 L - - ZS Laser, System, Excimer _(verified: each item appears in the quote below)_
- **Product:** BND Laser Hair Remover Models W-808 CW-808 (Epila and Venus Laser Hair Removal devices) | BND Laser Hair Remover Models W-808 CW-808 (Epila and Venus Laser Hair Removal devices) _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> BNB MEDICAL CO., LTD. Date Published : 08/22/2011 #404 Hyundai Hyel , 779-11 Jayang-Dong, Gwangjin-Gu , Seoul, KOREA (THE REPUBLIC OF) 79 K - - CX Epilator, High Frequency, Tweezer-Type Date Published: 08/22/2011 Desc: BND Laser Hair Remover Models W-808 CW-808 (Epila and Venus Laser Hair Removal devices) Notes: Class II 86 L - - ZS Laser, System, Excimer Date Published: 08/22/2011 Desc: BND Laser Hair Remover Models W-808 CW-808 (Epila and Venus Laser Hair Removal devices) Notes: Class II

## 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/).