# INNOFAITH BEAUTY SCIENCE · 89-08 · NETHERLANDS — FDA import alert red lists: firms subject to detention without physical examination

For INNOFAITH BEAUTY SCIENCE · 89-08 · NETHERLANDS, 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 NETHERLANDS; product is OBSERV 520X; 520X BEAUTY TOOL | OBSERV 520X; 520X BEAUTY TOOL | OBSERV 520X; 520X BEAUTY TOOL; product code is 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 79 N - - RJ Ultrasound, Skin Permeation | 79 P - - SN Light based imaging; date published is 03/11/2024; address is Science Park Eindhoven , 5204-B, 5692eg , Son, NETHERLANDS, verified against its source on 2026-09-16.

- **Firm:** INNOFAITH BEAUTY SCIENCE _(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:** NETHERLANDS _(verified: appears in the quote below)_
- **Address:** Science Park Eindhoven , 5204-B, 5692eg , Son, NETHERLANDS _(verified: appears in the quote below)_
- **Date published:** 03/11/2024 _(verified: appears in the quote below)_
- **Product code:** 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 79 N - - RJ Ultrasound, Skin Permeation | 79 P - - SN Light based imaging _(verified: each item appears in the quote below)_
- **Product:** OBSERV 520X; 520X BEAUTY TOOL | OBSERV 520X; 520X BEAUTY TOOL | OBSERV 520X; 520X BEAUTY TOOL _(verified: each item appears in the quote below)_

## What the source says

> INNOFAITH BEAUTY SCIENCE Date Published : 03/11/2024 Science Park Eindhoven , 5204-B, 5692eg , Son, NETHERLANDS 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 03/11/2024 Desc: OBSERV 520X; 520X BEAUTY TOOL 79 N - - RJ Ultrasound, Skin Permeation Date Published: 03/11/2024 Desc: OBSERV 520X; 520X BEAUTY TOOL 79 P - - SN Light based imaging Date Published: 03/11/2024 Desc: OBSERV 520X; 520X BEAUTY TOOL

## 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/).