Product Classification

• Device: low emission leds as indicators or decorations
• Definition: Finished LED products intended to act as an indicator or for decorative purposes, such as Christmas tree lights or display backlighting. LED product only intending to emit visible radiation at low intensities.
• Product Code: RIQ
• 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