K072072 is an FDA 510(k) clearance for the HARMONY LED-1 SURGICAL LIGHTING SYSTEM. This device is classified as a Light, Surgical, Ceiling Mounted (Class II - Special Controls, product code FSY).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on October 5, 2007, 67 days after receiving the submission on July 30, 2007.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K072072 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2007 |
| Decision Date | October 05, 2007 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FSY — Light, Surgical, Ceiling Mounted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |