Rha 2, Rha 3, Rha 4

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Implant, dermal, for aesthetic use

PMA Number

P170002 ↗

FDA Product Code

LMH

Device Class

Class III

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

• What are the key differences between the RHA 2, RHA 3, and RHA 4 in terms of injection depth and intended use?

  The RHA 2 and RHA 3 are designed for injection into the **mid-to-deep dermis**, while the RHA 4 is intended for injection into the **deep dermis to superficial subcutaneous tissue**. All three variants target the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), but their injection depth varies to address slightly different tissue layers for optimal results.

• Are the RHA 2, RHA 3, and RHA 4 single-use or reusable, and what does that mean for clinical workflow?

  The RHA series is explicitly labeled as a **sterile, single-use injectable product**, meaning each syringe or vial is intended for **one-time use only** by a qualified healthcare professional. This ensures patient safety and reduces the risk of contamination, requiring clinicians to use a new device per patient session.

• What age group is the RHA series approved for, and what does that imply for patient selection?

  The RHA 2, RHA 3, and RHA 4 are approved for use in **adults aged 22 years or older**, as specified in the FDA Premarket Approval (PMA) documentation. This age restriction ensures the device is used in patients whose skin and facial structures are fully developed, aligning with the intended treatment for dynamic wrinkles and folds.

• How should the RHA 2, RHA 3, and RHA 4 be stored, and is there any special handling required?

  While the exact storage conditions aren’t detailed in the provided data, the devices are **sterile and single-use**, so they must be stored according to standard sterile injectable product guidelines—typically in a **cool, dry place, protected from light**, and within the manufacturer’s expiration date. Always follow the included packaging instructions for optimal preservation.

• What regulatory pathway was followed for the RHA series, and how does that affect its availability?

  The RHA 2, RHA 3, and RHA 4 received **FDA Premarket Approval (PMA)** under PMA number **P170002**, indicating a rigorous review process for Class III devices. This approval ensures the devices meet strict safety and effectiveness standards, but availability depends on compliance with FDA regulations, including proper prescribing and administration by qualified healthcare professionals in clinical settings.