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Product Classification

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Device

laser, ophthalmic

Regulation Description

Ophthalmic laser.

Regulation Medical Specialty

Ophthalmic

Review Panel

Ophthalmic

Product Code

HQF

Submission Type

510(k)

Regulation Number

886.4390

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

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