K043155 is an FDA 510(k) clearance for the STARION UNIVERSAL POWER SUPPLY (UPS). This device is classified as a Unit, Cautery, Thermal, Ac-powered (Class II - Special Controls, product code HQO).
Submitted by Starion Instruments (Saratoga, US). The FDA issued a Cleared decision on December 9, 2004, 24 days after receiving the submission on November 15, 2004.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4115.
| 510(k) Number | K043155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2004 |
| Decision Date | December 09, 2004 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQO — Unit, Cautery, Thermal, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4115 |