K070871 is an FDA 510(k) clearance for the STARION UNIVERSAL POWER SUPPLY. This device is classified as a Unit, Cautery, Thermal, Ac-powered (Class II - Special Controls, product code HQO).
Submitted by Starion Instruments (Sunnyvale, US). The FDA issued a Cleared decision on April 13, 2007, 15 days after receiving the submission on March 29, 2007.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4115.
| 510(k) Number | K070871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2007 |
| Decision Date | April 13, 2007 |
| Days to Decision | 15 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 |