HRD · Sterilizer, Soft-Lens, Thermal, Ac-Powered
Ophthalmic · 21 CFR 886.5928 · Class 2
Overview
| Product Code | HRD |
|---|---|
| Device Name | Sterilizer, Soft-Lens, Thermal, Ac-Powered |
| Regulation | 21 CFR 886.5928 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
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.”
Special Controls
*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K822828 | SOFT LENS THERMAL DISINFECTING UNIT, A-C | Safeway Products, Inc. | Oct 29, 1982 | SESE |
Top Applicants
- Safeway Products, Inc. — 1 clearance
