(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.'' [62 FR 30988, June 6, 1997] Sec. 886.5933 [Reserved]