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U.S. Department of Health and Human Services

Product Classification

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Device sterilizer, soft-lens, thermal, battery-powered
Regulation Description Soft (hydrophilic) contact lens care products.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHRC
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)
Regulation Number 886.5928
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Documents
  • Premarket Notification 510(k) Guidance for Contact Lens Care Products [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080218.pdf] 
  • Guidance for Industry and Food and Drug Administration Staff - Contact Lens Care Products Labeling
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons