Product Classification

• Device: sterilizer, soft-lens, thermal, battery-powered
• Regulation Description: Soft (hydrophilic) contact lens care products.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: HRC
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: 510(k)
• Regulation Number: 886.5928
• 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
• 10-86 ISO 14729 First edition 2001-04-15
  Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010]
• 10-103 ANSI Z80.18-2016 (R2021)
  American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology
• 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

Guidance Document

• Premarket Notification 510(k) Guidance for Contact Lens Care Products

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