21 C.F.R. § 886.5928

Current through October 31, 2024
Section 886.5928 - Soft (hydrophilic) contact lens care products
(a)Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
(b)Classification. Class II (Special Controls) Guidance Document: "Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products."

21 C.F.R. §886.5928

62 FR 30988, June 6, 1997