Aquavit Life Sciences, Inc. · 89-08 · KOREA (THE REPUBLIC OF)
For Aquavit Life Sciences, Inc. · 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 Advance Skin Application Platform Micro Infusion System (ASAP!); AQT-002 | AQUAGOLD Fine Touch (AQT-001) | AQUAGOLD Fine Touch (AQT-001) | Advance Skin Application Platform Micro Infusion System (ASAP!); AQT-002 | AQUAGOLD Fine Touch (AQT-001) | Advance Skin Application Platform Micro Infusion System (ASAP!); AQT-002; product code is 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 09 Skin Fresheners (Skin Care Preparations) | 79 G - - AA Needle, Aspiration And Injection, Disposable | 79 G - - AA Needle, Aspiration And Injection, Disposable | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device; date published is 12/28/2021; address is 192 Beon-Gil 14 Bundang , 4 Th Floor Pankyoyeok-Ro , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Aquavit Life Sciences, Inc. 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
- 192 Beon-Gil 14 Bundang , 4 Th Floor Pankyoyeok-Ro , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 12/28/2021 verified
- Product code
- 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 09 Skin Fresheners (Skin Care Preparations) | 79 G - - AA Needle, Aspiration And Injection, Disposable | 79 G - - AA Needle, Aspiration And Injection, Disposable | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device each item verified
- Product
- Advance Skin Application Platform Micro Infusion System (ASAP!); AQT-002 | AQUAGOLD Fine Touch (AQT-001) | AQUAGOLD Fine Touch (AQT-001) | Advance Skin Application Platform Micro Infusion System (ASAP!); AQT-002 | AQUAGOLD Fine Touch (AQT-001) | Advance Skin Application Platform Micro Infusion System (ASAP!); AQT-002 each item verified
What the source says
Aquavit Life Sciences, Inc. Date Published : 12/28/2021 192 Beon-Gil 14 Bundang , 4 Th Floor Pankyoyeok-Ro , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 03/26/2024 Desc: Advance Skin Application Platform Micro Infusion System (ASAP!); AQT-002 53 L - - 09 Skin Fresheners (Skin Care Preparations) Date Published: 03/26/2024 Desc: AQUAGOLD Fine Touch (AQT-001) 79 G - - AA Needle, Aspiration And Injection, Disposable Date Published: 12/28/2021 Desc: AQUAGOLD Fine Touch (AQT-001) 79 G - - AA Needle, Aspiration And Injection, Disposable Date Published: 03/26/2024 Desc: Advance Skin Application Platform Micro Infusion System (ASAP!); AQT-002 79 Q - - AI Powered microneedle device Date Published: 12/28/2021 Desc: AQUAGOLD Fine Touch (AQT-001) 79 Q - - AI Powered microneedle device Date Published: 03/26/2024 Desc: Advance Skin Application Platform Micro Infusion System (ASAP!); AQT-002
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html