Product Classification

• Device: laser, ent microsurgical carbon-dioxide
• Regulation Description: Ear, nose, and throat microsurgical carbon dioxide laser.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Product Code: EWG
• Premarket Review: Office of Device Evaluation (ODE); Division of Ophthalmic and Ear, Nose and Throat Devices (DOED); Ear, Nose, and Throat Devices Branch (ENTB)
• Submission Type: 510(k)
• Regulation Number: 874.4500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible

Recognized Consensus Standard

• 12-273 IEC 60825-1 Edition 2.0 2007-03
  Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• accelerated device approval services, llc
• regulatory technology services, llc
• third party review group, llc
• tuv sud america inc.