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ASA LASER SH1

by El.En Electronic Engineering Spa 510(k)

Active United States

510(k) K122125

Overview

The ASA LASER SH1 is a device that provides topical heating for the purpose of elevating tissue temperature. It is intended for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm.

The device is supplied by El.En Electronic Engineering Spa and has received FDA 510(k) clearance with product code ILY. It is intended for use in physical medicine applications and was cleared on January 25, 2013.

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

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122125 Date25 Jan 2013ClearedStatusActive

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

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Questions

  • What is the ASA LASER SH1 device used for?

    The ASA LASER SH1 is a device that provides topical heating to elevate tissue temperature. It is intended for the temporary relief of muscle and joint pain, stiffness, arthritis pain, or muscle spasm in physical medicine applications.

  • How is the ASA LASER SH1 supplied?

    The ASA LASER SH1 device is supplied by El.En Electronic Engineering Spa. The manufacturer is located in Calenzano, Italy, and the device has received FDA 510(k) clearance with product code ILY.

  • Is the ASA LASER SH1 a single-use or reusable device?

    The device data does not specify whether the ASA LASER SH1 is single-use or reusable. For information on usage and disposal, please consult the manufacturer's instructions or contact El.En Electronic Engineering Spa directly.

  • What regulatory approvals does the ASA LASER SH1 have?

    The ASA LASER SH1 has received FDA 510(k) clearance with product code ILY. It was cleared on January 25, 2013, as substantially equivalent to predicate devices for use in physical medicine applications.