The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the counterfeit version of Ulthera® System. Please see particulars/details of the original vs. the counterfeit products as provided below:
- Ulthera® System
The Market Authorization Holder (MAH), Merz Philippines Healthcare Inc., reported to the FDA that the aforementioned medical device system is counterfeit.
Counterfeit product has not gone through the required safety assessment and the FDA verification process. This product pose potential health hazards to the public since its safety and effectiveness cannot be guaranteed.
In light of the foregoing, the public is advised not to purchase the aforementioned violative product.
All concerned establishments are warned not to distribute and use, the said counterfeit medical device system.
All FDA Regional Offices and Regulatory Enforcement Unit in coordination with law enforcement agencies and Local Government Units are requested to ensure that this violative product is not sold or made available in the market or their areas of jurisdiction.
The Bureau of Customs is urged to restrain the entry of this counterfeit product.
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 unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Dissemination of this advisory to all concerned is hereby requested.