Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

Device Code: 4432

Product Code(s): LOI

Device Classification Information

• Device Type ID: 4432
• Device Name: Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
• 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: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: LOI
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

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
• 12-268 IEC 60601-2-22 Edition 3.1 2012-10
  Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
• 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: 4432
• Device: Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
• Product Code: LOI
• FDA Device Classification: Class 3 Medical Device

TPLC Last Update: 2019-04-02 20:49:01