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

FDA 510(k)

StarFormer (M008-3T)

K-Number: K241785 · 2025-03-27

ApplicantFotona D.O.O.
Decision Date2025-03-27
Product CodeQPL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StarFormer (M008-3T) 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 2025-03-27 under 510(k) number K241785. The device is classified under product code QPL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StarFormer (M008-3T)?

StarFormer (M008-3T) is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is Fotona D.O.O.. The 510(k) number is K241785.

When did StarFormer (M008-3T) receive FDA 510(k) clearance?

StarFormer (M008-3T) received FDA 510(k) clearance on 2025-03-27, under 510(k) number K241785.

Who is the listed applicant for StarFormer (M008-3T)?

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 (M008-3T)?

The FDA product code for StarFormer (M008-3T) is QPL.

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.

K242202LightWalker Laser System FamilyK234061StarFormerK221274StarFormer, TightWaveK223540AvalancheLase FamilyK221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)K213267Dynamis Pro Family

View all 16 devices →

Related Devices (Code: QPL)

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.

K250309BTL-199BTL Industries, Inc.K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)The Magstim Company LimitedK233364Axon TherapyNeuralace Medical, Inc.K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionTonica Elektronik A/SK210021Axon TherapyNeuralace Medical, Inc.

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.

↑