Reference Source

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
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 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

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

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