TempSure System— 510(k) K223292

Name: FDA 510(k) clearance K223292
Creator: U.S. Food and Drug Administration
Published: 2022-11-23

Substantially Equivalent

Cynosure, LLC

FDA 510(k) clearance K223292 for TempSure System, Substantially Equivalent on 2022-11-23. Applicant: Cynosure, LLC. Device class: 2.

Clearance details

Applicant: Cynosure, LLC
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2022-10-26
Decision date: 2022-11-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Wesford, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cynosure, LLC

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K261570 — PICOSURE WORKSTATION2026-06-17
K240396 — Elite iQ PRO (M122K1)2024-03-08
K230510 — MyEllevate2023-07-06
K212891 — TempSure System2022-03-18
K210226 — PicoSure Workstation2021-03-30

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.