PMA P170002

Device: RHA Redensity® Eye Lido; RHA Redensity® Eye
Applicant: Teoxane S.A.
PMA number: P170002
Supplement: S025
Product code: LMH
Decision date: 2026-05-12
Generic name: Implant, dermal, for aesthetic use
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.

Current openFDA PMA Record#

Device: RHA Redensity® Eye Lido; RHA Redensity® Eye
Applicant: Teoxane S.A.
PMA number: P170002
Supplement: S050
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-05-12
Decision code: APPR
Date received: 2025-08-29
Supplement type: Panel Track
Supplement reason: Change Design/Components/Specifications/Material
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.