Product Classification

• Device: light based imaging
• Regulation Description: Surgical lamp.
• Definition: Emission and collection of light to create an image for medical purposes
• Physical State: Device is a light source in a housing and light detectors in a housing that can be aimed at a target tissue
• Technical Method: Device emits light that is collected from the target tissue and then analyzed to provide information about the target
• Target Area: Intact human skin
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: PSN
• Premarket Review: General Surgery Devices (DHT4A); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 878.4580
• 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• smo india clinical research pvt. ltd.
• third party review group, llc