Boston Aesthetics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Boston Aesthetics, Inc.” (first 2025, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 208 days. Since 2017 the median was 208 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 2 | 154 |
| 2026 | 4 | 208 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Boston Aesthetics, Inc. took a median 208 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| FTC | Light, Ultraviolet, Dermatological | 1 | 1 |
Review panels
Most recent Boston Aesthetics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253245 | Boston 2910 (Boston 2910) | GEX | 2026-05-21 | 234 |
| K251981 | Boston PICO (Boston PICO) | GEX | 2026-01-30 | 217 |
| K252369 | Boston Pico755 | GEX | 2026-01-21 | 175 |
| K251988 | Boston iFace (Boston iFace) | GEI | 2026-01-12 | 199 |
| K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) | FTC | 2025-03-13 | 76 |
| K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) | GEI | 2025-02-13 | 233 |
Recalls
openFDA lists no recalls under a recalling firm named Boston Aesthetics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Boston Scientific Corp (730 510(k)s)
- Boston Scientific Scimed, Inc. (35 510(k)s)
- Boston Medical Products, Inc. (33 510(k)s)
- Boston Scientific, Target (19 510(k)s)
- Boston Surgical Products, Inc. (17 510(k)s)
- Boston Biomedica, Inc. (12 510(k)s)
- Boston Pacific Medical, Inc. (11 510(k)s)
- Boston Scientific Neuromodulation (10 510(k)s)
- Boston Medical Corp. (8 510(k)s)
- Boston Scientific /International Technologies (5 510(k)s)
- Boston Scientific/Medi-Tech (5 510(k)s)
- Boston Brace Intl., Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Boston Aesthetics, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Boston Aesthetics, Inc.” (first 2025, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Boston Aesthetics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Boston Aesthetics, Inc. is 208 days. Since 2017: 208 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Boston Aesthetics, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 3); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); FTC (Light, Ultraviolet, Dermatological, 1).
Next steps
- See all 6 Boston Aesthetics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Boston Aesthetics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.