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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® Eye Lido; RHA Redensity® Eye
Generic NameImplant, dermal, for aesthetic use
ApplicantTeoxane S.A.
Les Charmilles Rue De Lyon, 105
Geneva 1203
PMA NumberP170002
Supplement NumberS050
Date Received08/29/2025
Decision Date05/12/2026
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for RHA Redensity® Eye Lido and RHA Redensity® Eye for expanding the indications to include injection into the sub-dermis and supraperiosteum for the correction of moderate to severe tissue volume deficiencies in the infraorbital region in adults aged 22 years or older.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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