Product Classification

• Device: 3d laser scanning system
• Definition: A 3d laser scanning system to be used in an accurate free form process to capture physical objects and produce a complete digital representation of the object for applications such as reverse engineering, prototyping, design, modeling, or others.
• Product Code: RHZ
• 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