# Aquavit Life Sciences, Inc. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** 192 Beon-Gil 14 Bundang , 4 Th Floor Pankyoyeok-Ro , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 12/28/2021 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_

## 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

## 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/).