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FDA 510(k)

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)

K-Number: K250391 · 2025-07-02

ApplicantElekta Solutions AB
Decision Date2025-07-02
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Solutions AB. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250391. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)?

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Elekta Solutions AB. The 510(k) number is K250391.

When did Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) receive FDA 510(k) clearance?

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250391.

Who is the listed applicant for Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)?

The FDA 510(k) record lists Elekta Solutions AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)?

The FDA product code for Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) is IWB.

Other records listing Elekta Solutions AB 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.

K261932Leksell® Vantage Stereotactic SystemK252002Monaco RTP System (6.3)K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)K251363ProKnow DSK232854Leksell GammaPlan (LGP)K223233Monaco RTP System

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Related Devices (Code: IWB)

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.

K232854Leksell GammaPlan (LGP)Elekta Solutions ABK222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions ABK203250TaiChiCOur United CorporationK203146Akesis Galaxy RTiAkesis, Inc.K200050Akesis Galaxy RTxAkesis, Inc.K190844Akesis GalaxyAkesis, 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.

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