BNB MEDICAL CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF)
For BNB MEDICAL CO., LTD., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 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 2026-09-30.
- 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)
— 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, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html