K110528 is an FDA 510(k) clearance for the INTEGRA LED SURGICAL HEADLIGHT SYSTEM. This device is classified as a Light, Headband, Surgical (Class II - Special Controls, product code FSR).
Submitted by Integra LifeSciences Corporation (York, US). The FDA issued a Cleared decision on May 11, 2011, 76 days after receiving the submission on February 24, 2011.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4335.
| 510(k) Number | K110528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2011 |
| Decision Date | May 11, 2011 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | FSR — Light, Headband, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4335 |