K922409 is an FDA 510(k) clearance for the ALM ILLUMINATOR SERIES LIGHT SYSTEM, a Light, Surgical, Instrument (Class II — Special Controls, product code FSQ), submitted by Alm Surgical Equipment, Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 12, 1993, 236 days after receiving the submission on May 21, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K922409 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 21, 1992 |
| Decision Date | January 12, 1993 |
| Days to Decision | 236 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FSQ — Light, Surgical, Instrument |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |