Product Classification

• Device: lens, contact, for reading discomfort
• Regulation Description: Soft (hydrophilic) contact lens.
• Definition: This lens is indicated for daily wear for the correction of refractive ametropia in persons with non-diseased eyes. This lens may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: NIC
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: 510(k)
• Regulation Number: 886.5925
• 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

• 10-77 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc