Laser, Ent Microsurgical Carbon-dioxide

Device Code: 1470

Product Code(s): EWG

Device Classification Information

• Device Type ID: 1470
• Device Name: Laser, Ent Microsurgical Carbon-dioxide
• Regulation Description: Ear, Nose, And Throat Microsurgical Carbon Dioxide Laser.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Ear, Nose, And Throat Devices Branch (ENTB)
• Submission Type: 510(k)
• CFR Regulation Number: 874.4500 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: EWG
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 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: 1470
• Device: Laser, Ent Microsurgical Carbon-dioxide
• Product Code: EWG
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Ear, Nose, And Throat Microsurgical Carbon Dioxide Laser.
• CFR Regulation Number: 874.4500 [🔎]

Device Problems
Device Operational Issue	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:54:34