FDA Advisory No. 2019-465 || Lifting the Advisory on the Following Registered Medical Devices under FDA Advisory No. 2019-342 and 2019-343 “Luxe Organix Hydrocolloid Acne Spot Patch Day Time and Luxe Organix Hydrocolloid Acne Spot Patch Night Time”

The Food and Drug Administration (FDA) informs the public that the following medical devices have been registered by the Market Authorization Holder (MAH), Genson Distribution, Inc., in accordance to existing FDA rules and regulations.

1. Luxe Organix Hydrocolloid Acne Spot Patch Day Time, with Registration No. MDR-08696.
2. Luxe Organix Hydrocolloid Acne Spot Patch Night Time, with Registration No. MDR-08697. 

Accordingly, the warning against the purchase and use of the products as mentioned in FDA Advisory No. 2019-342 and 2019-343 is hereby lifted.

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) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

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.

Attachment:->FDA ADVISORY No. 2019-465

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-465 || Lifting the Advisory on the Following Registered Medical Devices under FDA Advisory No. 2019-342 and 2019-343 “Luxe Organix Hydrocolloid Acne Spot Patch Day Time and Luxe Organix Hydrocolloid Acne Spot Patch Night Time”