INNOFAITH BEAUTY SCIENCE · 89-08 · NETHERLANDS
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
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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