K041598 is an FDA 510(k) clearance for the LASEREX, MODEL LP4532. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Ellex Medical Pty, Ltd. (Adelaide, South Australia, AU). The FDA issued a Cleared decision on October 6, 2004, 114 days after receiving the submission on June 14, 2004.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K041598 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2004 |
| Decision Date | October 06, 2004 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQF - Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |