Sterilizer, Soft-lens, Thermal, Battery-powered

Device Code: 4312

Product Code(s): HRC

Device Classification Information

• Device Type ID: 4312
• Device Name: Sterilizer, Soft-lens, Thermal, Battery-powered
• Regulation Description: Soft (hydrophilic) Contact Lens Care Products.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Contact Lenses And Retinal Devices Branch (CLRD)
• Submission Type: 510(k)
• CFR Regulation Number: 886.5928 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: HRC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 10-60 ISO 11981 Second Edition 2009-07-01
  Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Determination Of Physical Compatibility Of Contact Lens Care Products With Contact Lenses
• 10-67 ISO 11986 Second Edition 2010-11-01
  Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Guidelines For Determination Of Preservation Uptake And Release
• 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
  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

Total Product Life Cycle

• Device Type ID: 4312
• Device: Sterilizer, Soft-lens, Thermal, Battery-powered
• Product Code: HRC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Soft (hydrophilic) Contact Lens Care Products.
• CFR Regulation Number: 886.5928 [🔎]

TPLC Last Update: 2019-04-02 20:46:47