K982063 is an FDA 510(k) clearance for the ALM PRISMALIX (PRX) SURGICAL LIGHT, a Light, Surgical, Ceiling Mounted (Class II — Special Controls, product code FSY), submitted by Alm Surgical Equipment, Inc. (Anaheim, US). The FDA issued a Cleared decision on September 22, 1998, 102 days after receiving the submission on June 12, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K982063 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 12, 1998 |
| Decision Date | September 22, 1998 |
| Days to Decision | 102 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 |