Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cynosure, LLC — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

61 daysmedian FDA review time
189 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261570PICOSURE WORKSTATIONCynosure, LLC2026-06-17360
K240396Elite iQ PRO (M122K1)Cynosure, LLC2024-03-08290
K230510MyEllevateCynosure, LLC2023-07-061320
K223292TempSure SystemCynosure, LLC2022-11-23280
K212891TempSure SystemCynosure, LLC2022-03-181890
K210226PicoSure WorkstationCynosure, LLC2021-03-30610
K200241TempSure SystemCynosure, LLC2020-03-25540
K193426Elite iQCynosure, LLC2020-03-09900

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda