Product Classification

• Device: laser therapy product
• Definition: Non-surgical laser used on parts of the human body for therapeutic uses, such as pain management.
• Product Code: RHL
• Device Class: Not Classified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible

Third Party Review

Not Third Party Eligible