K984124 is an FDA 510(k) clearance for the AESCULAP XENON LIGHT SOURCE. This device is classified as a Light, Surgical, Floor Standing (Class II - Special Controls, product code FSS).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on February 1, 1999, 75 days after receiving the submission on November 18, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K984124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1998 |
| Decision Date | February 01, 1999 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FSS — Light, Surgical, Floor Standing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |