Product Classification

• Device: laser, microsurgical argon, for use in otology
• Regulation Description: Argon laser for otology, rhinology, and laryngology.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Product Code: LXR
• Submission Type: 510(k)
• Regulation Number: 874.4490
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• IEC 60601-2-22 (1995) Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment - Edition 2.0
• IEC 60825-1 (Second edition - 2007) Safety of laser products - Part 1: Equipment classification and requirements CORRIGENDUM 1
• IEC 60825-1 (Second edition - 2007) I-SH 01 SAFETY OF LASER PRODUCTS - Part 1: Equipment classification and requirements, INTERPRETATION SHEET 1
• IEC 60825-1 (2007) Second Edition I-SH 02 SAFETY OF LASER PRODUCTS - Part 1: Equipment classifcation and requirements, INTERPRETATION SHEET 2
• IEC 60825-1 Ed. 2.0 (2007) Safety of laser products - Part 1: Equipment classification, and requirements

Third Party Review

• Eligible for Accredited Persons Program