# K252188: EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Solutions AB
- Decided: Jan 15, 2026 after 185 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K926449 (1995). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210500: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD, Elekta Limited (2021) Summary page 5.

## Indications for use
The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licensed medical practitioner. It is intended to assist a licensed medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. Elekta Synergy and Elekta Harmony are the default entry-level configurations. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, and hypofractionation in all areas of the body where such treatment is indicated. Elekta Infinity and Elekta Harmony Pro are the default mid-level configuration. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy — SBRT; stereotactic ablative radiotherapy — SABR) in all areas of the body where such treatment is indicated. Versa HD and Elekta Evo are the default high-level configuration. It is intended to be used for single or multiple fractions using standard fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy — SBRT; stereotactic ablative radiotherapy — SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated and for the treatment of functional disorders, such as trigeminal neuralgia. The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.

Source page: https://510kreport.com/device/K252188
Methodology: https://510kreport.com/methodology