Laser, System, Phacolysis

Device Code: 4362

Product Code(s): MXO

Device Classification Information

• Device Type ID: 4362
• Device Name: Laser, System, Phacolysis
• Regulation Description: Phacofragmentation System.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Diagnostic And Surgical Devices Branch (DSDB)
• Submission Type: 510(k)
• CFR Regulation Number: 886.4670 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MXO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 10-66 ISO 10936-2 Second Edition 2010-01-15
  Optics And Photonics - Operation Microscopes - Part 2: Light Hazard From Operation Microscopes Used In Ocular Surgery
• 10-72 ISO 15004-1 First Edition 2006-06-01
  Ophthalmic Instruments - Fundamental Requirements And Test Methods - Part 1: General Requirements Applicable To All Ophthalmic Instruments
• 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)]

Total Product Life Cycle

• Device Type ID: 4362
• Device: Laser, System, Phacolysis
• Product Code: MXO
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Phacofragmentation System.
• CFR Regulation Number: 886.4670 [🔎]

TPLC Last Update: 2019-04-02 20:47:38