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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRHA® Redensity, RHA® Redensity Mepi
Generic NameImplant, dermal, for aesthetic use
ApplicantTeoxane S.A.
Les Charmilles Rue De Lyon, 105
Geneva 1203
PMA NumberP170002
Supplement NumberS052
Date Received01/06/2026
Decision Date07/02/2026
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT06378086
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the final labeling of RHA® Redensity Mepi. This follows the completion of the post-approval study to investigate whether RHA® Redensity™ Mepi (with mepivacaine) is non-inferior to RHA® Redensity™ (with lidocaine) for injection site pain felt during injection in FST V/VI subjects.
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