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SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)

by Cure Point Therapeutics, Inc. 510(k)

Active United States

510(k) K231997

Overview

The SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) is a physical medicine device that has been determined to be substantially equivalent to a predicate device. It is classified under product code ILY and was reviewed by the Physical Medicine advisory committee.

The device received traditional 510(k) clearance from the FDA on October 15, 2024, under K number K231997. It is manufactured by Cure Point Therapeutics, Inc. and was submitted for review on July 5, 2023. The device is authorized for distribution in the United States.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231997 Date15 Oct 2024ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ILY
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Other devices from Cure Point Therapeutics, Inc.

Questions

  • What is the SIRONA 100 Therapy Laser System used for?

    The SIRONA 100 Therapy Laser System is a physical medicine device intended for therapeutic applications in physical medicine, as determined by its substantial equivalence to a predicate device and review by the Physical Medicine advisory committee.

  • How was the SIRONA 100 Therapy Laser System cleared for market?

    The device received traditional 510(k) clearance from the FDA on October 15, 2024, under K number K231997, following a submission on July 5, 2023, based on a determination of substantial equivalence to a predicate device.

  • Who manufactures the SIRONA 100 Therapy Laser System and where is it located?

    The SIRONA 100 Therapy Laser System is manufactured by Cure Point Therapeutics, Inc., located at 1712 Pioneer Ave., Suite 2606, Cheyenne, WY 82001, United States.