PicoSure Workstation
FDA 510(k) K210226 · Cynosure, LLC
510(k) numberK210226
Submission
- Device name
- PicoSure Workstation
- Applicant
- Cynosure, LLC
Wesford, MA, US - Received
- January 28, 2021
- Decision date
- March 30, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
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More from Rhein Laser Technologies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261570 | Picosure WorkstationGEX · Special | 06/17/2026SE |
| K240396 | Elite iQ PRO (M122K1)GEX · Special | 03/08/2024SE |
| K230510 | MyEllevateGAT · Traditional | 07/06/2023SE |
| K223292 | TempSure SystemGEI · Special | 11/23/2022SE |
| K212891 | TempSure SystemGEI · Traditional | 03/18/2022SE |
| K200241 | TempSure SystemPBX · Traditional | 03/25/2020SE |
| K193426 | Elite iQGEX · Traditional | 03/09/2020SE |
| K190678 | TempSureGEI · Traditional | 07/24/2019SE |
| K182741 | SculpSurePKT · Traditional | 01/03/2019SE |
| K182365 | TempSure SystemGEI · Traditional | 10/24/2018SE |
Questions and answers
When was PicoSure Workstation cleared by the FDA?
PicoSure Workstation (K210226) received a 510(k) decision of Substantially Equivalent on March 30, 2021, 61 days after the submission was received.
What is the product code of K210226?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.