Product Classification

• Device: endoilluminator, reprocessed
• Regulation Description: Endoscope and accessories.
• Definition: Used intraocularly to provide light into the posterior of the eye during retinal surgery. Same as product code MPA, except this one is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Ophthalmic
• Product Code: NKZ
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: 510(k)
• Regulation Number: 876.1500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 10-65 ISO 15752 Second edition 2010-01-15
  Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
• 10-130 ANSI Z80.36-2021
  American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments

Third Party Review

Not Third Party Eligible