21 CFR 886.5918 — Products, Contact Lens Care, Rigid Gas Permeable
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5918
Identification
A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.
Classification Rationale
Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 2 | 33 | 3rd Party |
Special Controls
MRC — Products, Contact Lens Care, Rigid Gas Permeable
*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
eCFR
MRC — Products, Contact Lens Care, Rigid Gas Permeable
Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
Ecfr Llm
