K083595 is an FDA 510(k) clearance for the EZLASE. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Biolase Technology, Inc. (Irvine, US). The FDA issued a Cleared decision on April 14, 2009, 130 days after receiving the submission on December 5, 2008.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K083595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2008 |
| Decision Date | April 14, 2009 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILY — Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |