LXS · Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Ophthalmic · 21 CFR 886.4392 · Class 2
Overview
| Product Code | LXS |
|---|---|
| Device Name | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Regulation | 21 CFR 886.4392 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
The Nd:YAG laser for posterior capsulotomy and peripheral iridotomy consists of a mode-locked or Q-switched solid state Nd:YAG laser intended for disruption of the posterior capsule or the iris via optical breakdown. The Nd:YAG laser generates short pulse, low energy, high power, coherent optical radiation. When the laser output is combined with focusing optics, the high irradiance at the target causes tissue disruption via optical breakdown. A visible aiming system is utilized to target the invisible Nd:YAG laser radiation on or in close proximity to the target tissue.
Classification Rationale
Class II (special controls). Design Parameters: Device must emit a laser beam with the following parameters: wavelength = 1064 nanometers; spot size = 50 to 100 micros; pulse width = 3 to 30 nanoseconds; output energy per pulse = 0.5 to 15 millijoules (mJ); repetition rate = 1 to 10 pulses; and total energy = 20 to 120 mJ.
Special Controls
*Classification.* Class II (special controls). Design Parameters: Device must emit a laser beam with the following parameters: wavelength = 1064 nanometers; spot size = 50 to 100 micros; pulse width = 3 to 30 nanoseconds; output energy per pulse = 0.5 to 15 millijoules (mJ); repetition rate = 1 to 10 pulses; and total energy = 20 to 120 mJ.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023045 | MICRORUPTER V | Meridian AG | Sep 26, 2002 | SESE |
| K901605 | PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. | Phoenix Laser Systems, Inc. | Dec 13, 1990 | SESE |
| K895864 | MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP | Lasag AG | Dec 29, 1989 | SESE |
| K893987 | NIDEK MODEL YC-1200 | Nidek, Inc. | Aug 18, 1989 | SESE |
| K892204 | NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS | Nidek, Inc. | Jun 22, 1989 | SESE |
| K892058 | ISL QC 2000 | Intelligent Surgical Lasers, Inc. | Jun 15, 1989 | SESE |
| P840047 | CILCO ND:YAG LASER | Coopervision-Cilco | Aug 2, 1985 | APRL |
Top Applicants
- Nidek, Inc. — 2 clearances
- Coopervision-Cilco — 1 clearance
- Intelligent Surgical Lasers, Inc. — 1 clearance
- Lasag AG — 1 clearance
- Meridian AG — 1 clearance
