DongBang Medical Co. Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For DongBang 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 Derma-Q For Microneedle | Dermapen Needle | Derma-Q For Microneedle; product code is 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 79 G - - AB Needle, Suturing, Disposable | 79 M - - DM Instrument, Manual, General Surgical; date published is 10/22/2015; address is Saneopdanji-Gil 30/40 , Ungcheon-Eup , Boryeong, Chungcheongnam KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- DongBang 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
- Saneopdanji-Gil 30/40 , Ungcheon-Eup , Boryeong, Chungcheongnam KOREA (THE REPUBLIC OF) verified
- Date published
- 10/22/2015 verified
- Product code
- 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 79 G - - AB Needle, Suturing, Disposable | 79 M - - DM Instrument, Manual, General Surgical each item verified
- Product
- Derma-Q For Microneedle | Dermapen Needle | Derma-Q For Microneedle each item verified
- FDA notes
- The device has no 510(k) clearance or PMA approval verified
What the source says
DongBang Medical Co. Ltd. Date Published : 10/22/2015 Saneopdanji-Gil 30/40 , Ungcheon-Eup , Boryeong, Chungcheongnam KOREA (THE REPUBLIC OF) 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 04/21/2016 Desc: Derma-Q For Microneedle Notes: 79 G - - AB Needle, Suturing, Disposable Date Published: 10/22/2015 Desc: Dermapen Needle Notes: The device has no 510(k) clearance or PMA approval 79 M - - DM Instrument, Manual, General Surgical Date Published: 04/21/2016 Desc: Derma-Q For Microneedle Notes:
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html