21 CFR 886.5928 — Sterilizer, Soft-Lens, Thermal, Battery-Powered
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5928
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.
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 |
|---|---|---|---|---|
| HRC | Sterilizer, Soft-Lens, Thermal, Battery-Powered | 2 | 1 | 3rd Party |
| HRD | Sterilizer, Soft-Lens, Thermal, Ac-Powered | 2 | 1 | 3rd Party |
| LPN | Accessories, Soft Lens Products | 2 | 122 | 3rd Party |
| LRX | Case, Contact Lens | 2 | 82 | 3rd Party |
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | 2 | 22 | 3rd Party |
Special Controls
HRC — Sterilizer, Soft-Lens, Thermal, Battery-Powered
*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
eCFR
HRD — Sterilizer, Soft-Lens, Thermal, Ac-Powered
*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
eCFR
LPN — Accessories, Soft Lens Products
*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
eCFR
LRX — Case, Contact Lens
*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
eCFR
LYL — Accessories, Solution, Ultrasonic Cleaners For Lenses
*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
eCFR
