Cynosure, Inc.
FDA Regulatory Profile
Cynosure, Inc. appears in FDA public data with 1 recall, 107 510(k) clearances, 11 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0169-2015, Class II) was initiated on October 9, 2014. Its most recent 510(k) clearance was granted on June 17, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 107
- Inspections
- 11
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0169-2015 | Class II | Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System | October 9, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261570 | PICOSURE WORKSTATION | June 17, 2026 |
| K240396 | Elite iQ PRO (M122K1) | March 8, 2024 |
| K230510 | MyEllevate | July 6, 2023 |
| K223292 | TempSure System | November 23, 2022 |
| K212891 | TempSure System | March 18, 2022 |
| K210226 | PicoSure Workstation | March 30, 2021 |
| K200241 | TempSure System | March 25, 2020 |
| K193426 | Elite iQ | March 9, 2020 |
| K190678 | TempSure | July 24, 2019 |
| K182741 | SculpSure | January 3, 2019 |
| K182365 | TempSure System | October 24, 2018 |
| K173199 | PicoSure Workstation | February 7, 2018 |
| K171992 | SculpSure | September 26, 2017 |
| K171262 | TempSure | September 22, 2017 |
| K171111 | Sculpsure | June 13, 2017 |
| K160470 | SculpSure | July 21, 2016 |
| K160480 | PicoSure Workstation | May 17, 2016 |
| K150724 | SculpSure | July 1, 2015 |
| K150230 | SculpSure | May 15, 2015 |
| K143105 | Picosure Workstation | February 23, 2015 |