Name: Predicase
Price: 199 USD

K-number	K240297
Device name	Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)
Applicant	Us Medical Innovations, LLC
Product code	OAB
Device class	Class II
Decision date	May 3, 2024
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)

Everything you need for a 510(k) submission. Nothing you don't.

Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)