Product Classification

• Device: high intensity lamp
• Definition: High intensity mercury vapor or metal halide lamp, intended for general purpose illumination, but of such a design that breakage of an outer envelope will not result in increased uv emissions.
• Product Code: RIA
• Device Class: Not Classified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: Yes

    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.

• Summary Malfunction Reporting: Ineligible

Third Party Review

Not Third Party Eligible