Product Classification

• Device: sterilizer, soft-lens, thermal, ac-powered
• Regulation Description: Soft (hydrophilic) contact lens care products.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: HRD
• 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

• ISO 11981 Second edition 2009-07-01 Ophthalmic optics -- Contact lenses and contact lens car products -- Determination of physical compatibility of contact lens care products with contact lenses
• ISO 9394 Second edition 1998-08-15 Ophthalmic optics -- Contact lenses and contact lens care products -- Determination of biocompatibility by ocular study using rabbit eyes
• ISO 11986 Second edition 2010-11-01 Ophthalmic optics -- Contact lenses and contact lens care products -- Guidelines for determination of preservation uptake and release
• ISO 11980 Second edition 2009-10-15 Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations
• ISO 14729 First edition 2001-04-15 Amendment 1 2010-10-01 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses

Guidance Documents

• Premarket Notification 510(k) Guidance for Contact Lens Care Products  
• Guidance for Industry and Food and Drug Administration Staff - Contact Lens Care Products Labeling

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• tuv sud america inc.
• underwriters laboratories, inc.