| I. System Description
The New Star Model
1500 is a compact, portable, self-contained system that produces
a beam of infrared radiation at 2,100 nm wavelength. With energy
delivered in 350 µs pulse widths, this laser is ideal for
the treatment of kidney stones and other applications in urology,
as well as ENT and PLDD. The pulsed laser beam is delivered to
the treatment site using a fiber optic delivery system. The repetition
of the treatment beam is adjustable to 5, 8, 10 or 12 Hz for varying
conditions.
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II. Console Description
The console measures
36" high, 14" wide, and 21" deep and weighs only 120 pounds. The
system operates from 115 or 230 VAC service. The console includes
the control panel, laser head assembly, power supply, and a cooling
system. It also comes equipped with an ON/OFF key switch and Emergency
Off switch.
Control Panel: The
control panel is located on top of the laser console and contains
all the controls required by the operator to set power, rep rate
and perform data collection functions.
US
Federal law restricts this device To Sale by or On the Order of a
Physician
|
NS 1500 is
CE marked and has ETL safety approvals.
New Star Lasers Regulatory
Status as of 4/25/06
| PRODUCT |
APPLICATION |
STATUS |
510(K)# |
| Model
1500 Ho:YAG@2,100nm |
General/Orthopedic
Surgery |
Cleared
2/21/92 |
K912879 |
| Lithotripsy
(Ureteral) |
Cleared
3/8/95 |
K945156 |
| Soft
Tissue (Urology) |
Cleared
9/1/94 |
K942542 |
| PLDD
(Percutaneous Laser Disc Decompression) |
Cleared
7/21/92 |
K920248 |
| 15 Watt Model
for the Indications Above |
Cleared
3/9/93 |
K925549 |
| Endosinus |
Cleared
1/10/94 |
K933007 |
|
Expanded
|
Cleared
1/20/00 |
K994273 |
|
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