Erchonia EMERGE

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K130996 ↗

FDA Product Code

NHN

Device Class

Class II

Regulation

21 CFR Part 890.5500

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• LunulaLaser

  Class II

  FDA 510(k) K153164 Active Cleared 3 Jun 2016

• Erchonia Verju Laser System with Massager

  Class II

  FDA 510(k) K130922 Active Cleared 17 May 2013

• Erchonia Allay

  Class II

  FDA 510(k) K132940 Active Cleared 14 Apr 2014

• Erchonia IOTO_240

  Class II

  FDA 510(k) K062792 Active Cleared 1 Mar 2007

• Erchonia PL5000

  Class II

  FDA 510(k) K130741 Active Cleared 23 Apr 2013

• Erchonia Ml Scanner (Mls)

  Class II

  FDA De Novo DEN090008 Active Cleared 24 Aug 2010 FDA 510(k)

See all devices from Erchonia Medical, Inc. →

• What is the Erchonia EMERGE used for in clinical settings?

  The Erchonia EMERGE is designed as an adjunctive tool in pain management protocols within physical medicine. It emits specific wavelengths of light to interact with tissue non-thermally, helping to support pain therapy without causing heat-related damage. This makes it suitable for use alongside other physical medicine interventions to address chronic or acute pain conditions.

• Is the Erchonia EMERGE a single-use or reusable device?

  The Erchonia EMERGE is supplied as a reusable medical device. It is intended for repeated clinical use under proper handling and maintenance protocols as outlined by the manufacturer. Reusability is a key factor in its design, allowing for cost-effective integration into physical medicine workflows.

• What regulatory pathway does the Erchonia EMERGE follow?

  The Erchonia EMERGE is regulated under the FDA’s 510(k) clearance pathway, specifically under the classification for Powered Light-Based Laser Non-Thermal Instruments. It holds clearance number K130996 and falls under product code NHN, with a regulatory designation of 890.5500. This classification ensures it meets FDA standards for adjunctive use in pain therapy within physical medicine settings.

• Does the Erchonia EMERGE require any special handling or storage conditions?

  While the regulatory data does not specify sterility requirements or MRI safety considerations, the Erchonia EMERGE must be handled according to the manufacturer’s guidelines to ensure proper functionality and longevity. As a reusable device, it should be cleaned and maintained per Erchonia Medical’s instructions to prevent contamination or damage. Storage should follow standard practices for medical lasers to avoid exposure to environmental factors that could compromise performance.

• What distinguishes the Erchonia EMERGE from other laser devices in pain therapy?

  The Erchonia EMERGE is distinguished by its non-thermal design, meaning it delivers light-based treatment without generating heat, which reduces the risk of tissue damage. This differentiates it from thermal lasers and positions it as a specialized tool for adjunctive pain management in physical medicine. Its FDA clearance for this specific use further validates its role in targeted, non-invasive pain therapy protocols.