Esteya

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K132092

by Nucletron B.V.

Identity

Trade Name: Esteya FDA UDI
Generic Name: Skin-tumour low-voltage therapeutic x-ray system FDA UDI
Device Name: Surface Applicator, 10mm FDA UDI
Model / Reference: 187157P01-00 FDA UDI
Description: Surface Applicator, 10mm FDA UDI

Identifiers

Primary DI / UDI-DI: 08717213051034 FDA UDI
510(k) Number: K132092 FDA 510(k)FDA UDI
FDA Product Code: JAD FDA 510(k)FDA UDI
GMDN Term: Skin-tumour low-voltage therapeutic x-ray system FDA UDI

Classification

Device Class: Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 892.5900 FDA 510(k)
Regulation Number: 892.5900 FDA 510(k)FDA UDI
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 10.0 Millimeter FDA UDI

The Esteya is a System, Therapeutic, X-Ray device, classified as Class II. It is used in radiology.

The Esteya is supplied by Nucletron B.V. and has been cleared by the FDA with a 510K clearance. It has a product code of JAD and is regulated under regulation number 892.5900. The device has been assigned multiple FEI numbers and registration numbers, and has undergone multiple clearances, with the most recent one being in 2022.

Frequently asked questions

What is the Esteya used for?

The Esteya is used in radiology for therapeutic purposes, utilizing X-ray technology to provide treatment.

Is the Esteya cleared by the FDA?

Yes, the Esteya has been cleared by the FDA with a 510K clearance, indicating it is substantially equivalent to a predicate device.

What type of device is the Esteya classified as?

The Esteya is classified as a Class II therapeutic X-ray device, regulated under regulation number 892.5900.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K213942 FDA 510(k) - Esteya | Nucletron B.V. - 510kdatabase.net, Esteya 510 (k) FDA Premarket Notification K213942 Nucletron B.V., Nucletron Esteya - allmed.wiki, PDF Nucletron B.V. Kiran Jose Regulatory Affairs Senior Engineer 3900 Ax ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K132092	Class II	Active

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Manufacturer

Manufacturer: Nucletron B.V.

Sources (2)

FDA 510(k) K132092 24 fields · synced Sep 21, 2026
FDA UDI 8305db13-051e-42a4-8aec-43337f4fd652 36 fields · synced May 26, 2026