Reference Source

May Pharm · 89-08 · KOREA (THE REPUBLIC OF)

For May Pharm, 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 METOO Fill Deep; Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | METOO Fill Volume | METOO Fill Deep; Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | METOO Fill Volume | METOO Fill Deep; Cross-linked Hyaluronic Acid | METOO Fill Volume | Cross-linked Hyaluronic Acid; product code is 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 04/14/2025; address is 205-27 Gasan Digital , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.

Firm
May Pharm 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
205-27 Gasan Digital , Seoul, KOREA (THE REPUBLIC OF) verified
Date published
04/14/2025 verified
Product code
53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular each item verified
Product
METOO Fill Deep; Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | METOO Fill Volume | METOO Fill Deep; Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | METOO Fill Volume | METOO Fill Deep; Cross-linked Hyaluronic Acid | METOO Fill Volume | Cross-linked Hyaluronic Acid each item verified
FDA notes
Class III | Class III | Class III | Class III | Class III | Class III | Class III | Class III | Class III 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

May Pharm Date Published : 04/14/2025 205-27 Gasan Digital , Seoul, KOREA (THE REPUBLIC OF)

— accessdata.fda.gov, retrieved 2026-09-22

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

53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 04/14/2025 Desc: METOO Fill Deep; Cross-linked Hyaluronic Acid Notes: Class III 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 04/14/2025 Desc: Cross-linked Hyaluronic Acid Notes: Class III 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 04/14/2025 Desc: METOO Fill Volume Notes: Class III 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 04/14/2025 Desc: METOO Fill Deep; Cross-linked Hyaluronic Acid Notes: Class III 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 04/14/2025 Desc: Cross-linked Hyaluronic Acid Notes: Class III 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 04/14/2025 Desc: METOO Fill Volume Notes: Class III 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 04/14/2025 Desc: METOO Fill Deep; Cross-linked Hyaluronic Acid Notes: Class III 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 04/14/2025 Desc: METOO Fill Volume Notes: Class III 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 04/14/2025 Desc: Cross-linked Hyaluronic Acid Notes: Class III

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

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