Product Classification

• Device: lamp, surgical
• Regulation Description: Surgical lamp.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: FTD
• Submission Type: 510(k)
• Regulation Number: 878.4580
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Guidance Document for Surgical Lamp 510(k)s; Final

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.