TempSure
FDA 510(k) K190678 · Cynosure, Inc.
510(k) numberK190678
Submission
- Device name
- TempSure
- Applicant
- Cynosure, Inc.
Wesford, MA, US - Received
- March 18, 2019
- Decision date
- July 24, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K223292 | TempSure SystemGEI · Special | 11/23/2022SE |
| K212891 | TempSure SystemGEI · Traditional | 03/18/2022SE |
| K210226 | PicoSure WorkstationGEX · Traditional | 03/30/2021SE |
| K200241 | TempSure SystemPBX · Traditional | 03/25/2020SE |
| K193426 | Elite iQGEX · Traditional | 03/09/2020SE |
| K182741 | SculpSurePKT · Traditional | 01/03/2019SE |
| K182365 | TempSure SystemGEI · Traditional | 10/24/2018SE |
Questions and answers
When was TempSure cleared by the FDA?
TempSure (K190678) received a 510(k) decision of Substantially Equivalent on July 24, 2019, 128 days after the submission was received.
What is the product code of K190678?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.