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Electronic Code of Federal Regulations

e-CFR data is current as of March 26, 2020

Title 21Chapter ISubchapter HPart 886Subpart F → §886.5928


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart F—Therapeutic Devices


§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.”

[62 FR 30988, June 6, 1997]

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