INNOFAITH BEAUTY SCIENCE · 89-08 · NETHERLANDS
For INNOFAITH BEAUTY SCIENCE, import alert is 89-08; country is NETHERLANDS; 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 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 2026-09-30.
- Firm
- INNOFAITH BEAUTY SCIENCE 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
- NETHERLANDS verified
- Address
- Science Park Eindhoven , 5204-B, 5692eg , Son, NETHERLANDS verified
- Date published
- 03/11/2024 verified
- 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 each item verified
- Product
- OBSERV 520X; 520X BEAUTY TOOL | OBSERV 520X; 520X BEAUTY TOOL | OBSERV 520X; 520X BEAUTY TOOL each item verified
What the source says
INNOFAITH BEAUTY SCIENCE Date Published : 03/11/2024 Science Park Eindhoven , 5204-B, 5692eg , Son, NETHERLANDS
— 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 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html