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FDA 510(k)

StarFormer

K-Number: K234061 · 2024-07-01

ApplicantFotona D.O.O.
Decision Date2024-07-01
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

StarFormer is the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.O.O.. It received FDA 510(k) clearance on 2024-07-01 under 510(k) number K234061. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StarFormer?

StarFormer is a medical device that received FDA 510(k) clearance on 2024-07-01. The listed applicant is Fotona D.O.O.. The 510(k) number is K234061.

When did StarFormer receive FDA 510(k) clearance?

StarFormer received FDA 510(k) clearance on 2024-07-01, under 510(k) number K234061.

Who is the listed applicant for StarFormer?

The FDA 510(k) record lists Fotona D.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StarFormer?

The FDA product code for StarFormer is KPI.

Other records listing Fotona D.O.O. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 16 devices →

Related Devices (Code: KPI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.