The original approval. In 2017, FDA approved RHA 2 and RHA 3 for injection into the mid-to-deep dermis, and RHA 4 for injection into the deep dermis to superficial subcutaneous tissue, each for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds, in adults aged 22 or older.
Later approvals. FDA has expanded the line through supplements to P170002. RHA Redensity was approved on December 22, 2021 for moderate to severe dynamic perioral rhytids (lines around the mouth), injected into the dermis and superficial dermis. RHA 3's indication was expanded on October 27, 2023 to include lip augmentation and lip fullness. RHA 4 and RHA Dynamic Volume were expanded on September 18, 2025 to include cheek augmentation and correction of age-related midface contour deficiencies. RHA Redensity Eye and RHA Redensity Eye Lido were expanded on May 12, 2026 to include correction of moderate to severe tissue volume deficiencies in the infraorbital region (under the eyes). Each indication is for adults aged 22 or older.
What this means in the treatment room. Approval is product-specific and area-specific. RHA 3 carries the lip indication; RHA Redensity carries the perioral-lines indication; the under-eye indication belongs to the RHA Redensity Eye products. Using one RHA product in an area approved only for another is off-label.
How to verify. Search "P170002" in FDA's PMA database. The original approval and each supplement are listed with dates and approval statements.
Business information, not medical or legal advice. Verify current status and labeling at FDA.gov before purchasing or treating.
