Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MultiCut Solo

K-Number: K213597 · 2023-01-18

Decision Date2023-01-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MultiCut Solo is a medical device manufactured by Asclepion Laser Technologies GmbH. It received FDA 510(k) clearance on 2023-01-18 under approval number K213597. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MultiCut Solo?

MultiCut Solo is a medical device that received FDA 510(k) clearance on 2023-01-18. It is manufactured by Asclepion Laser Technologies GmbH. The 510(k) number is K213597.

When was MultiCut Solo approved by the FDA?

MultiCut Solo received FDA 510(k) clearance on 2023-01-18, under approval number K213597.

What company makes MultiCut Solo?

MultiCut Solo is manufactured by Asclepion Laser Technologies GmbH.

What is the FDA product code for MultiCut Solo?

The FDA product code for MultiCut Solo is GCJ.

Other Devices by Asclepion Laser Technologies GmbH

View all 11 devices →

Related Devices (Code: GCJ)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.