Data / Medical devices / United States / Boston Aesthetics Inc
Boston Aesthetics Inc: FDA-registered device maker in Irvine, CA, United States, 7 510(k) clearances
Boston Aesthetics Inc is registered with the FDA (registration 3036425107) in Irvine, CA, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 21, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3036425107
- Address
- 1 Peters Canyon Rd Ste 100 Irvine Ca 92606, Irvine, CA, United States, 92606
- Owner or operator
- Boston Aesthetics INC (10092784)
- Roles
- Complaint file establishment
- First device listed
- February 18, 2025
- Registered through
- 2027
- Brand names listed
- 308nm UV Phototherapy System, Model: UV-K; UV-X; UV-Y; UV-Z, Boston 2910, Boston PICO, Boston Pico755, Boston iFace, Unicorn+ RF System, Modle: Unicorn+, Unicorn+ I, Unicorn+ II, Unicorn+ III, ZenTite, Model: Unicorn+, Unicorn+ I, Unicorn+ II, Unicorn+ III
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment | accessdata.fda.gov |
| Light, Ultraviolet, Dermatological | FTC | 2 | Complaint file establishment | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 21, 2026 | K253245 | Boston 2910 (Boston 2910) | GEX | Substantially Equivalent | Boston Aesthetics, Inc. | accessdata.fda.gov |
| January 30, 2026 | K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) | GEI | Substantially Equivalent | Shenzhen Peninsula Medical Group | accessdata.fda.gov |
| January 30, 2026 | K251981 | Boston PICO (Boston PICO) | GEX | Substantially Equivalent | Boston Aesthetics, Inc. | accessdata.fda.gov |
| January 21, 2026 | K252369 | Boston Pico755 | GEX | Substantially Equivalent | Boston Aesthetics, Inc. | accessdata.fda.gov |
| January 12, 2026 | K251988 | Boston iFace (Boston iFace) | GEI | Substantially Equivalent | Boston Aesthetics, Inc. | accessdata.fda.gov |
| March 13, 2025 | 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 | Substantially Equivalent | Boston Aesthetics, Inc. | accessdata.fda.gov |
| February 13, 2025 | K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) | GEI | Substantially Equivalent | Boston Aesthetics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Light, Ultraviolet, Dermatological
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated May 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.