BNB MEDICAL CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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
- Address
- #404 Hyundai Hyel , 779-11 Jayang-Dong, Gwangjin-Gu , Seoul, KOREA (THE REPUBLIC OF) verified
- Date published
- 08/22/2011 verified
- Product code
- 79 K - - CX Epilator, High Frequency, Tweezer-Type | 86 L - - ZS Laser, System, Excimer each item verified
- 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) each item verified
- FDA notes
- Class II | Class II each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html