DeviceClearance

Product code NHN— Physical Medicine

ERCHONIA EML LASER

Classification name
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Device class
Class 2
Regulation
21 CFR 890.5500
Advisory panel
Physical Medicine
Total cleared
54
First cleared
Most recent

FDA classification definition

“A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication. It does not provide therapeutic topical heating. The classification regulation for infrared lamps describes a device that emits energy in the infrared wavelength to provide topical heating and that is not limited to adjunctive use.”

— U.S. Food and Drug Administration, device classification record for product code NHN under 21 CFR 890.5500, via openFDA

Market context for product code NHN

FDA has cleared 54 devices under product code NHN between 2002 and 2026, filed by 31 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code NHN

Recent clearances under product code NHN

Data sourced from openFDA. This site is unofficial and independent of the FDA.