HRD — Sterilizer, Soft-Lens, Thermal, Ac-Powered Class II
FDA product code HRD covers "Sterilizer, Soft-Lens, Thermal, Ac-Powered", a Class II medical device regulated under 21 CFR 886.5928. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- HRD
- Device Class
- Class II
- Regulation Number
- 886.5928
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K822828 | safeway products | SOFT LENS THERMAL DISINFECTING UNIT, A-C | October 29, 1982 |