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FDA 510(k)

Medical Laser System Incanto / Evoline Platinum /Evoline

K-Number: K243630 · 2025-03-21

ApplicantSolar LS Cjsc
Decision Date2025-03-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Laser System Incanto / Evoline Platinum /Evoline is a medical device manufactured by Solar LS Cjsc. It received FDA 510(k) clearance on 2025-03-21 under approval number K243630. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Laser System Incanto / Evoline Platinum /Evoline?

Medical Laser System Incanto / Evoline Platinum /Evoline is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Solar LS Cjsc. The 510(k) number is K243630.

When was Medical Laser System Incanto / Evoline Platinum /Evoline approved by the FDA?

Medical Laser System Incanto / Evoline Platinum /Evoline received FDA 510(k) clearance on 2025-03-21, under approval number K243630.

What company makes Medical Laser System Incanto / Evoline Platinum /Evoline?

Medical Laser System Incanto / Evoline Platinum /Evoline is manufactured by Solar LS Cjsc.

What is the FDA product code for Medical Laser System Incanto / Evoline Platinum /Evoline?

The FDA product code for Medical Laser System Incanto / Evoline Platinum /Evoline is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

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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.

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