K100234 is an FDA 510(k) clearance for the HM-LAMP II, a Lamp, Surgical (Class II — Special Controls, product code FTD), submitted by Hillusa, Inc. (Miami, US). The FDA issued a Cleared decision on July 8, 2010, 163 days after receiving the submission on January 26, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K100234 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 26, 2010 |
| Decision Date | July 08, 2010 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTD — Lamp, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |