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  1. Device Approvals, Denials and Clearances

RHA® 2, RHA® 3, and RHA® 4 Dermal Fillers - P170002

RHA® 2, RHA® 3, and RHA® 4 Dermal Fillers - P170002

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: RHA®2, RHA®3 and RHA®4 Dermal Fillers
PMA Applicant: TEOXANE SA
Address: Les Charmilles, Rue de Lyon, 105, CH - 1203, Geneva, Switzerland
Approval Date: October 19, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170002A.pdf

What is it? RHA Dermal Fillers are clear, colorless, injectable gels that can correct facial wrinkles and folds, such as nasolabial folds. RHA Dermal Fillers come in 3 different formulations: RHA® 2, RHA® 3, and RHA® 4. Each contains hyaluronic acid made using a Streptococcus equi bacterial strain. They also contain a small amount of local anesthetic (lidocaine) to help reduce pain of the injection.

How does it work? A doctor injects the RHA® 2, RHA® 3, or RHA® 4 gel into the facial tissue to smooth facial wrinkles and folds, such as nasolabial folds.

When is it used? RHA® 2, RHA® 3, and RHA® 4, are used in adults aged 22 years or older with moderate to severe facial wrinkles and folds. The doctor selects which formulation to use based on the depth of the desired injection. RHA® 2 and RHA® 3 are indicated for injection into the mid to deep dermis while RHA® 4 is indicated to be injected into the deep dermis to superficial subcutaneous tissue of the face.

What will it accomplish? 24 weeks after treatment, RHA® 2, RHA® 3 and RHA® 4 were found to smooth the appearance of moderate to severe folds and wrinkles, such as nasolabial folds.

Common side effects include:

  • bruising
  • discoloration
  • firmness
  • itching
  • lumps/bumps
  • pain
  • redness
  • swelling
  • tenderness

When should it not be used? RHA® 2, RHA® 3 and RHA® 4 should not be used in patients who have:

  • severe allergies, such as a history of a severe hypersensitivity (anaphylaxis) or history or presence of multiple severe allergies,
  • a history of allergies to gram positive bacterial proteins, or
  • previous hypersensitivity to local anesthetics, such as lidocaine,
  • bleeding disorders.

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online. 

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