Product Classification

• Device: powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
• Regulation Description: Infrared lamp.
• 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.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: NHN
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neuromodulation and Rehabilitation Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 890.5500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 12-242 IEC 60601-2-57 Edition 1.0 2011-01
  Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
• 12-355 IEC 60601-2-57 Edition 2.0 2023-07
  Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use

Guidance Document

• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices

Third Party Review

Not Third Party Eligible