Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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