The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the medical device product, STYLAGE IPN – LIKE TECHNOLOGY M LIDOCAINE, has been issued an FDA Certificate of Medical Device Registration to the Market Authorization Holder (MAH), AJ Research & Pharma Inc., in accordance to existing FDA rules and regulations.
Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2022-1001 dated 27 April 2022 for the specific product is hereby lifted.
The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected] or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of unnotified medical device, contact the online reporting facility, eReport, through e-mail at [email protected].
The public health warning imposed on the remaining products listed in FDA Advisory No. 2021-3527 shall remain to be upheld and shall not be affected by the issuance of this advisory.
Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations. Dissemination of this advisory to all concerned is hereby requested.