---
kind: "section"
citation: "21 C.F.R. § 886.5928"
title: "21"
number: "886.5928"
heading: "Soft (hydrophilic) contact lens care products."
url: "https://uscodex.org/cfr/21/886.5928"
---

# §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.”

## Notes

### Amendments

[62 FR 30988, June 6, 1997]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

### Amendments

[62 FR 30988, June 6, 1997]