LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
Device Facts
| Record ID | K001772 |
|---|---|
| Device Name | LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA |
| Applicant | Taracan Pty. , Ltd. |
| Product Code | HQF · Ophthalmic |
| Decision Date | Jul 6, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 886.4390 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.
