Selecta
PBL200051, Rev J
22 Safety and Regulatory
Regulatory compliance labels
SN
P/N
Model name, serial number, a nd
manufacturing date
0044
(for products shipped under
the Medical Device Directive)
CE mark
MADE IN U.S.A.
U.S. AND INTERNATIONAL
PATENTS PENDING
Patents pending
CAUTION:
U.S. FEDERAL LAW RESTRICTS
THIS DEVICE TO SALE BY OR ON
ORDER OF A PHYSICIAN
FDA sales restriction
(for FDA-compliant systems)
THIS PRODUCT COMPLIES
WITH 21 CFR, CHAPTER I,
SUBCHAPTER J
DHHS certification
ETL label Electrical specification
100-240 V~
50/60 Hz
3.15A
Danger label
Lumenis contact information
3959 West 1820 South
Salt Lake City, UT 84104 U.S.A.
LUMENIS (Germany) GmbH
Heinrich-Hertz-Strasse 3
D-63303 Dreieich, Germany
+49.6103.8335.0
CONFORMS TO
UL STD 60601-1
CERTIFIED TO
3030552
CAN/CSA STD C22.2 NO 601.1
ETL CLASSIFIED
CLASS 3B LASER PRODUCT per IEC 60825-1/2001
CLASS IIIb LASER PRODUCT per 21 CFR 1040
VISIBLE AND INVISIBLE LASER RADIATION
AVOID EXPOSURE TO BEAM
CLASS 3B LASER PRODUCT
Nd:YAG: 532 nm, 2 mJ Max / 3 ns pulse
Nd:YAG: 1064 nm, 10 mJ Max / 3 ns pulse
VISIBLE LASER RADIATION
DO NOT STARE INTO BEAM
CLASS 2 LASER PRODUCT
Diode Laser: 635 nm, <1 mW Max, CW
LB-006280 Rev C
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