FDA 510(k) clearance · back to tracker
Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)
Us Medical Innovations, LLC cleared K240297 on 2024-05-03, decision: substantially equivalent
K-number
K240297
Sponsor
Us Medical Innovations, LLC
Device
Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)
Class
Class II
Decision
Substantially Equivalent
Decision date
2024-05-03
Product code
OAB
Advisory committee
General, Plastic Surgery
Medical specialty
General, Plastic Surgery
Regulation number
878.4400
Official FDA record
Open K240297on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
openFDA JSON
Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
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Drop K240297 into Compass and start a substantial-equivalence draft.
Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.
Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.