TempSure System
FDA 510(k) K182365 · Cynosure, Inc.
510(k) numberK182365
Submission
- Device name
- TempSure System
- Applicant
- Cynosure, Inc.
Wesford, MA, US - Received
- August 30, 2018
- Decision date
- October 24, 2018
- 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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Questions and answers
When was TempSure System cleared by the FDA?
TempSure System (K182365) received a 510(k) decision of Substantially Equivalent on October 24, 2018, 55 days after the submission was received.
What is the product code of K182365?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.