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

FDA 510(k)

LASER THERMAL THERAPY KIT

K-Number: K260632 · 2026-03-17

ApplicantElesta S.P.A
Decision Date2026-03-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER THERMAL THERAPY KIT is a medical device manufactured by Elesta S.P.A. It received FDA 510(k) clearance on 2026-03-17 under approval number K260632. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER THERMAL THERAPY KIT?

LASER THERMAL THERAPY KIT is a medical device that received FDA 510(k) clearance on 2026-03-17. It is manufactured by Elesta S.P.A. The 510(k) number is K260632.

When was LASER THERMAL THERAPY KIT approved by the FDA?

LASER THERMAL THERAPY KIT received FDA 510(k) clearance on 2026-03-17, under approval number K260632.

What company makes LASER THERMAL THERAPY KIT?

LASER THERMAL THERAPY KIT is manufactured by Elesta S.P.A.

What is the FDA product code for LASER THERMAL THERAPY KIT?

The FDA product code for LASER THERMAL THERAPY KIT is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT07615361 Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy ENROLLING_BY_INVITATION NCT07613489 Photobiomodulation for Diabetic Peripheral Neuropathy ACTIVE_NOT_RECRUITING NCT07615920 HILT vs ESWT in Supraspinatus Tendinitis NOT_YET_RECRUITING NCT05738239 Photo-biomodulation Therapy for Pain Relief After Caesarean Section COMPLETED NCT07137728 Dual Frequency Low-Level Laser Therapy in Myofascial Trigger Points of Upper Trapezius COMPLETED

Other Devices by Elesta S.P.A

K213594ECHOLASER X4 K230460Laser Thermal Therapy Kit

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.

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.

↑