Product Classification

• Device: laser, neodymium:yag, ophthalmic for posterior capsulotomy and cutting pupilla
• Regulation Description: Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: LXS
• Submission Type: 510(k)
• Regulation Number: 886.4392
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• IEC 60825-1 Ed. 2.0 (2007) Safety of laser products - Part 1: Equipment classification, and requirements
• 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 60601-2-22 Third Edition 2007-05 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
• IEC 60825-1 (Second edition - 2007) Safety of laser products - Part 1: Equipment classification and requirements CORRIGENDUM 1
• ISO 10936-2 Second edition 2010-01-15 Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery
• ISO 15004-1 First edition 2006-06-01 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
• 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

Guidance Document

• Guidance on the Content and Organization of a Premarket Notification for a Medical Laser

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
• tuv sud america inc.
• underwriters laboratories, inc.