K093009 is an FDA 510(k) clearance for the MACH LED SC. This device is classified as a Light, Surgical, Ceiling Mounted (Class II - Special Controls, product code FSY).
Submitted by Dr. Mach GmbH & Co. KG (Ebersberg, DE). The FDA issued a Cleared decision on April 1, 2010, 184 days after receiving the submission on September 29, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K093009 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2009 |
| Decision Date | April 01, 2010 |
| Days to Decision | 184 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 |