# Across Co., Ltd · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Across 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 REVOLAX | REVOLAX | REVOLAX; product code is 60 Q - - 40 Lidocaine HCl (Anesthetic) | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 08/22/2022; address is 3F, 23, Geodudanji 1-gil , Dongnae-myeon , Chuncheon-si, Gangwon-do KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Across Co., Ltd _(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:** 3F, 23, Geodudanji 1-gil , Dongnae-myeon , Chuncheon-si, Gangwon-do KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 08/22/2022 _(verified: appears in the quote below)_
- **Product code:** 60 Q - - 40 Lidocaine HCl (Anesthetic) | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular _(verified: each item appears in the quote below)_
- **Product:** REVOLAX | REVOLAX | REVOLAX _(verified: each item appears in the quote below)_

## What the source says

> Across Co., Ltd Date Published : 08/22/2022 3F, 23, Geodudanji 1-gil , Dongnae-myeon , Chuncheon-si, Gangwon-do KOREA (THE REPUBLIC OF) 60 Q - - 40 Lidocaine HCl (Anesthetic) Date Published: 08/22/2022 Desc: REVOLAX 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 08/22/2022 Desc: REVOLAX 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 08/22/2022 Desc: REVOLAX

## 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/).