FDA approvals and recalls

Aesthetics: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

Device recalls

1 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

  • Eraser, Dental Stain

    Reason: Products were stored outside of labeled temperature requirements.

    Z-0268-2024

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

9 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

Side effects people report

2,891 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Botulism181 reports
  2. 2Therapeutic response decreased168 reports
  3. 3Injection site pain143 reports
  4. 4Headache111 reports
  5. 5Injection site swelling109 reports
  6. 6Therapeutic response shortened107 reports
  7. 7Vision blurred87 reports
  8. 8Injection site erythema73 reports
  9. 9Dysphagia69 reports
  10. 10Eyelid ptosis67 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

Market reports on aesthetics

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Medical Devices

Aesthetic Lasers and Energy Devices

Worldwide · 2024–2034

View report Medical Devices

Body Contouring

Worldwide · 2024–2034

View report Pharmaceuticals

Botulinum Toxin Aesthetics

Worldwide · 2024–2034

View report Healthcare Services

Cosmetic Surgery

Worldwide · 2024–2034

View report Medical Devices

Dermal Fillers

Worldwide · 2024–2034

View report OTC & Nutraceuticals

Dermocosmetics

Worldwide · 2024–2034

View report

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Acuitas market sizes and forecasts are only in our full reports. How we use public data.