Product Classification

• Device: lens, contact (rigid gas permeable), extended wear
• Regulation Description: Rigid gas permeable contact lens.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: MWL
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: PMA
• Regulation Number: 886.5916
• Device Class: 3
• 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

• 10-77 ISO 9394 Third edition 2012-10-01
  Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
• 10-85 ISO 11980 Third edition 2012-11-15 Corrected version 2012-12-01
  Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
• 10-100 ISO 18259 First Edition 2014-10-01
  Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
• 10-101 ISO 18189 First edition 2016-06-01
  Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
• 10-106 ISO 18369-3 Second edition 2017-08
  Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
• 10-107 ISO 18369-4 Second edition 2017-08
  Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
• 10-108 ISO 18369-2 Third edition 2017-08
  Ophthalmic optics - Contact lenses - Part 2: Tolerances
• 10-109 ISO 18369-1 Second edition 2017-08
  Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
• 10-111 ISO 11981 Third edition 2017-11
  Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
• 10-112 ISO 11986 Third edition 2017-11
  Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
• 10-129 ASTM D790-17
  Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

Guidance Document

• Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Final

Third Party Review

Not Third Party Eligible