PMA P170002

Device: RHA® Kiss Volume
Applicant: Teoxane S.A.
PMA number: P170002
Supplement: S025
Product code: LMH
Decision date: 2026-07-27
Generic name: Implant, dermal, for aesthetic use
Approval order statement: approval for updating the labeling of RHA®3 Mepi to a new commercial name, RHA® Kiss Volume, that includes a smaller gauge (30G) needle in its packaging, color change to the syringe finger grip and plunger rod, and updated labeling including use of 27G or 30G needle when injecting for both approved indications, in the lips and nasolabial folds.

Current openFDA PMA Record#

Device: RHA® Kiss Volume
Applicant: Teoxane S.A.
PMA number: P170002
Supplement: S055
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-07-27
Decision code: APPR
Date received: 2026-04-28
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for updating the labeling of RHA®3 Mepi to a new commercial name, RHA® Kiss Volume, that includes a smaller gauge (30G) needle in its packaging, color change to the syringe finger grip and plunger rod, and updated labeling including use of 27G or 30G needle when injecting for both approved indications, in the lips and nasolabial folds.