Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Boston Aesthetics, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
217 daysmedian FDA review time
234 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | 2026-05-21 | 234 | 0 |
| K251981 | Boston PICO (Boston PICO) | Boston Aesthetics, Inc. | 2026-01-30 | 217 | 0 |
| K252369 | Boston Pico755 | Boston Aesthetics, Inc. | 2026-01-21 | 175 | 0 |
| K251988 | Boston iFace (Boston iFace) | Boston Aesthetics, Inc. | 2026-01-12 | 199 | 0 |
| K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy S | Boston Aesthetics, Inc. | 2025-03-13 | 76 | 0 |
| K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ | Boston Aesthetics, Inc. | 2025-02-13 | 233 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda