Issued to Advance-Esthetic LLC. Serious post-market compliance violation.
Issued
August 25, 2026Product
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Company
Advance-Esthetic LLC
Review center
CDRHStage
Final Decision
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FDA issued a warning letter to Advance-Esthetic LLC concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on August 25, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.