FDA applicant
Boston Aesthetics, Inc.
FDA records 6 decisions for Boston Aesthetics, Inc. (Wilmington, DE) from 2025 to 2026: 6 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 208 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Boston Aesthetics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Boston Aesthetics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Boston”
FDA records each applicant name separately; these may or may not be the same firm.