Reference Source

Aquavit Life Sciences, Inc. · 89-08 · KOREA (THE REPUBLIC OF)

For Aquavit Life Sciences, Inc., 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 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 2026-09-30.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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)

— 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 and Product

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

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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