K140461 is an FDA 510(k) clearance for the MACH LED 2MC. This device is classified as a Light, Surgical, Ceiling Mounted (Class II - Special Controls, product code FSY).
Submitted by Dr. Mach GmbH & Co. KG (Norderstedt, Schleswig-Holstein, DE). The FDA issued a Cleared decision on April 3, 2014, 38 days after receiving the submission on February 24, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K140461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2014 |
| Decision Date | April 03, 2014 |
| Days to Decision | 38 days |
| Submission Type | Special |
| 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 |