Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/

Summary

The FDA issued a Class II for Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLT by Olympus Corporation of the Americas. Reason: Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause .

Details

Product Description

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

Lot/Code Info: Laser system: TFL-PLS; UDI: 00821925044111; Component Part: TFL-CPLU; UDI: 00821925044586; Serial #: MDUF220005, MDUF220005, MDUF220437, MDUF220437, MDUF220446, MDUF220446, MDUF190072, MDUF200324, MDUF210030, MDUF210204, MDUF210379, MDUF220001, MDUF220002, MDUF220003, MDUF220007, MDUF220008, MDUF220009, MDUF220010, MDUF220011, MDUF220012, MDUF220013, MDUF220014, MDUF220015, MDUF220016, MDUF220017, MDUF220018, MDUF220019, MDUF220020, MDUF220021, MDUF220022, MDUF220023, MDUF220024, MDUF220025, MDUF220026, MDUF220027, MDUF220028, MDUF220029, MDUF220030, MDUF220031, MDUF220032, MDUF220033, MDUF220034, MDUF220035, MDUF220036, MDUF220037, MDUF220038, MDUF220039, MDUF220040, MDUF220042, MDUF220043, MDUF220044, MDUF220045, MDUF220046, MDUF220047, MDUF220048, MDUF220049, MDUF220050, MDUF220051, MDUF220052, MDUF220053, MDUF220054, MDUF220055, MDUF220056, MDUF220057, MDUF220058, MDUF220060, MDUF220061, MDUF220062, MDUF220063, MDUF220064, MDUF220065, MDUF220066, MDUF220067, MDUF220069, MDUF220070, MDUF220071, MDUF220072, MDUF220074, MDUF220075, MDUF220076, MDUF220077, MDUF220078, MDUF220079, MDUF220080, MDUF220081, MDUF220082, MDUF220083, MDUF220084, MDUF220085, MDUF220086, MDUF220087, MDUF220088, MDUF220089, MDUF220090, MDUF220091, MDUF220092, MDUF220093, MDUF220094, MDUF220095, MDUF220096, MDUF220097, MDUF220098, MDUF220100, MDUF220101, MDUF220102, MDUF220103, MDUF220106, MDUF220109, MDUF220110, MDUF220111, MDUF220113, MDUF220114, MDUF220115, MDUF220116, MDUF220117, MDUF220119, MDUF220120, MDUF220123, MDUF220124, MDUF220126, MDUF220127, MDUF220128, MDUF220130, MDUF220131, MDUF220133, MDUF220135, MDUF220137, MDUF220138, MDUF220139, MDUF220140, MDUF220141, MDUF220142, MDUF220143, MDUF220144, MDUF220145, MDUF220146, MDUF220147, MDUF220149, MDUF220150, MDUF220151, MDUF220152, MDUF220153, MDUF220154, MDUF220155, MDUF220156, MDUF220157, MDUF220158, MDUF220159, MDUF220160, MDUF220161, MDUF220162, MDUF220163, MDUF220164, MDUF220165, MDUF220166, MDUF220167, MDUF220168, MDUF220170, MDUF220171, MDUF220172, MDUF220173, MDUF220174, MDUF220175, MDUF220176, MDUF220177, MDUF220178, MDUF220179, MDUF220180, MDUF220181, MDUF220182, MDUF220183, MDUF220184, MDUF220185, MDUF220186, MDUF220187, MDUF220188, MDUF220189, MDUF220190, MDUF220191, MDUF220192, MDUF220193, MDUF220194, MDUF220195, MDUF220196, MDUF220198, MDUF220199, MDUF220200, MDUF220201, MDUF220202, MDUF220203, MDUF220204, MDUF220205, MDUF220206, MDUF220207, MDUF220208, MDUF220209, MDUF220210, MDUF220211, MDUF220212, MDUF220213, MDUF220214, MDUF220216, MDUF220217, MDUF220218, MDUF220219, MDUF220220, MDUF220221, MDUF220222, MDUF220223, MDUF220224, MDUF220225, MDUF220226, MDUF220227, MDUF220228, MDUF220229, MDUF220230, MDUF220231, MDUF220232, MDUF220233, MDUF220234, MDUF220235, MDUF220237, MDUF220238, MDUF220240, MDUF220241, MDUF220242, MDUF220243, MDUF220244, MDUF220245, MDUF220246, MDUF220247, MDUF220248, MDUF220249, MDUF220250, MDUF220251, MDUF220252, MDUF220253, MDUF220254, MDUF220255, MDUF220256, MDUF220257, MDUF220258, MDUF220259, MDUF220260, MDUF220261, MDUF220262, MDUF220263, MDUF220264, MDUF220265, MDUF220266, MDUF220267, MDUF220268, MDUF220269, MDUF220270, MDUF220271, MDUF220272, MDUF220273, MDUF220274, MDUF220275, MDUF220276, MDUF220277, MDUF220278, MDUF220279, MDUF220280, MDUF220281, MDUF220283, MDUF220284, MDUF220285, MDUF220286, MDUF220287, MDUF220288, MDUF220289, MDUF220291, MDUF220292, MDUF220294, MDUF220295, MDUF220296, MDUF220297, MDUF220298, MDUF220299, MDUF220300, MDUF220301, MDUF220302, MDUF220303, MDUF220304, MDUF220305, MDUF220306, MDUF220307, MDUF220308, MDUF220309, MDUF220310, MDUF220311, MDUF220312, MDUF220313, MDUF220314, MDUF220315, MDUF220316, MDUF220317, MDUF220318, MDUF220320, MDUF220321, MDUF220322, MDUF220323, MDUF220324, MDUF220326, MDUF220327, MDUF220328, MDUF220329, MDUF220330, MDUF220332, MDUF220333, MDUF220334, MDUF220335, MDUF220336, MDUF220337, MDUF220338, MDUF220339, MDUF220340, MDUF220341, MDUF220342, MDUF220343, MDUF220344, MDUF220345, MDUF220346, MDUF220347, MDUF220348, MDUF220349, MDUF220350, MDUF220351, MDUF220358, MDUF220359, MDUF220360, MDUF220361, MDUF220362, MDUF220364, MDUF220365, MDUF220366, MDUF220367, MDUF220368, MDUF220370, MDUF220371, MDUF220373, MDUF220374, MDUF220375, MDUF220377, MDUF220378, MDUF220379, MDUF220380, MDUF220381, MDUF220382, MDUF220383, MDUF220384, MDUF220385, MDUF220388, MDUF220389, MDUF220391, MDUF220392, MDUF220394, MDUF220397, MDUF220399, MDUF220400, MDUF220402, MDUF220403, MDUF220404, MDUF220405, MDUF220406, MDUF220407, MDUF220408, MDUF220409, MDUF220410, MDUF220415, MDUF220416, MDUF220417, MDUF220418, MDUF220419, MDUF220420, MDUF220421, MDUF220423, MDUF220424, MDUF220425, MDUF220426, MDUF220428, MDUF220429, MDUF220431, MDUF220432, MDUF220433, MDUF220434, MDUF220435, MDUF220436, MDUF220438, MDUF220439, MDUF220440, MDUF220441, MDUF220442, MDUF220443, MDUF220444, MDUF220445, MDUF220448, MDUF220449, MDUF220450, MDUF220457, MDUF220458, MDUF220459, MDUF220460, MDUF220461, MDUF220462, MDUF220463, MDUF220464, MDUF220465, MDUF220466, MDUF220468, MDUF220469, MDUF220470, MDUF220471, MDUF220473, MDUF220476, MDUF220478, MDUF220481, MDUF220482, MDUF220483, MDUF220484, MDUF220485, MDUF220486, MDUF220488, MDUF220489, MDUF220492, MDUF220493, MDUF220494, MDUF220495, MDUF220496, MDUF220497, MDUF220498, MDUF220499, MDUF220500, MDUF220501, MDUF220502, MDUF220504, MDUF220505, MDUF220506, MDUF220507, MDUF220508, MDUF220509, MDUF220511, MDUF220512, MDUF220513, MDUF220515, MDUF220517, MDUF220518, MDUF220519, MDUF220520, MDUF220521, MDUF220523, MDUF220524, MDUF220525, MDUF220526, MDUF220527, MDUF220528, MDUF220530, MDUF220531, MDUF220532, MDUF220533, MDUF220534, MDUF220535, MDUF220536, MDUF220537, MDUF220538, MDUF220539, MDUF220541, MDUF220542, MDUF220543, MDUF220545, MDUF220546, MDUF220548, MDUF220550, MDUF220551, MDUF220552, MDUF220553, MDUF220554, MDUF220555, MDUF220556, MDUF220557, MDUF220558, MDUF220559, MDUF220560, MDUF220562, MDUF220563, MDUF220564, MDUF220565, MDUF220567, MDUF220568, MDUF220569, MDUF220570, MDUF220571, MDUF220572, MDUF220573, MDUF220574, MDUF220575, MDUF220576, MDUF220577, MDUF220578, MDUF220579, MDUF220580, MDUF220581, MDUF220582, MDUF220583, MDUF220584, MDUF220585, MDUF220586, MDUF220588, MDUF230002, MDUF230003, MDUF230008, MDUF230010, MDUF230011, MDUF230012, MDUF230014, MDUF230015, MDUF230016, MDUF230017, MDUF230019, MDUF230020, MDUF230021, MDUF230022, MDUF230023, MDUF230024, MDUF230025, MDUF230028, MDUF230030, MDUF230031, MDUF230032, MDUF230033, MDUF230034, MDUF230035, MDUF230036, MDUF230037, MDUF230038, MDUF230039, MDUF230040, MDUF230041, MDUF230042, MDUF230043, MDUF230044, MDUF230045, MDUF230046, MDUF230047, MDUF230048, MDUF230049, MDUF230050, MDUF230052, MDUF230053, MDUF230054, MDUF230055, MDUF230056, MDUF230057, MDUF230060, MDUF230061, MDUF230062, MDUF230064, MDUF230065, MDUF230067, MDUF230069, MDUF230070, MDUF230071, MDUF230072, MDUF230073, MDUF230074, MDUF230075, MDUF230077, MDUF230078, MDUF230079, MDUF230080, MDUF230081, MDUF230082, MDUF230084, MDUF230085, MDUF230086, MDUF230087, MDUF230088, MDUF230089, MDUF230090, MDUF230091, MDUF230092, MDUF230093, MDUF230094, MDUF230095, MDUF230096, MDUF230097, MDUF230098, MDUF230099, MDUF230102, MDUF230103, MDUF230104, MDUF230105, MDUF230106, MDUF230107, MDUF230108, MDUF230109, MDUF230110, MDUF230111, MDUF230112, MDUF230113, MDUF230114, MDUF230115, MDUF230116, MDUF230117, MDUF230118, MDUF230119, MDUF230120, MDUF230121, MDUF230122, MDUF230123, MDUF230124, MDUF230125, MDUF230126, MDUF230127, MDUF230128, MDUF230129, MDUF230130, MDUF230131, MDUF230132, MDUF230133, MDUF230134, MDUF230136, MDUF230137, MDUF230138, MDUF230139, MDUF230142, MDUF230143, MDUF230144, MDUF230145, MDUF230146, MDUF230147, MDUF230148, MDUF230149, MDUF230150, MDUF230151, MDUF230152, MDUF230153, MDUF230154, MDUF230156, MDUF230157, MDUF230158, MDUF230159, MDUF230160, MDUF230161, MDUF230162, MDUF230165, MDUF230168, MDUF230169, MDUF230170, MDUF230171, MDUF230172, MDUF230173, MDUF230174, MDUF230175, MDUF230176, MDUF230177, MDUF230178, MDUF230179, MDUF230180, MDUF230181, MDUF230182, MDUF230183, MDUF230184, MDUF230185, MDUF230186, MDUF230187, MDUF230188, MDUF230189, MDUF230190, MDUF230191, MDUF230192, MDUF230193, MDUF230194, MDUF230195, MDUF230196, MDUF230197, MDUF230198, MDUF230199, MDUF230200, MDUF230201, MDUF230202, MDUF230203, MDUF230204, MDUF230205, MDUF230206, MDUF230207, MDUF230208, MDUF230209, MDUF230210, MDUF230211, MDUF230212, MDUF230213, MDUF230214, MDUF230215, MDUF230216, MDUF230218, MDUF230219, MDUF230220, MDUF230221, MDUF230222, MDUF230223, MDUF230224, MDUF230226, MDUF230227, MDUF230228, MDUF230229, MDUF230230, MDUF230231, MDUF230232, MDUF230233, MDUF230235, MDUF230236, MDUF230237, MDUF230238, MDUF230239, MDUF230240, MDUF230241, MDUF230242, MDUF230243, MDUF230244, MDUF230245, MDUF230246, MDUF230247, MDUF230248, MDUF230249, MDUF230250, MDUF230251, MDUF230252, MDUF230253, MDUF230254, MDUF230255, MDUF230256, MDUF230257, MDUF230258, MDUF230259, MDUF230260, MDUF230261, MDUF230262, MDUF230263, MDUF230264, MDUF230265, MDUF230266, MDUF230267, MDUF230268, MDUF230269, MDUF230270, MDUF230272, MDUF230274, MDUF230275, MDUF230276, MDUF230277, MDUF230278, MDUF230279, MDUF230280, MDUF230281, MDUF230282, MDUF230286, MDUF230287, MDUF230288, MDUF230289, MDUF230290, MDUF230291, MDUF230292, MDUF230293, MDUF230294, MDUF230295, MDUF230296, MDUF230297, MDUF230298, MDUF230299, MDUF230300, MDUF230301, MDUF230302, MDUF230303, MDUF230304, MDUF230305, MDUF230306, MDUF230307, MDUF230308, MDUF230309, MDUF230310, MDUF230311, MDUF230314, MDUF230316, MDUF230317, MDUF230318, MDUF230319, MDUF230320, MDUF230321, MDUF230322, MDUF230324, MDUF230325, MDUF230326, MDUF230327, MDUF230328, MDUF230330, MDUF230333, MDUF230334, MDUF230335, MDUF230336, MDUF230337, MDUF230338, MDUF230339, MDUF230341, MDUF230342, MDUF230343, MDUF230344, MDUF230345, MDUF230346, MDUF230347, MDUF230348, MDUF230349, MDUF230350, MDUF230351, MDUF230352, MDUF230353, MDUF230354, MDUF230355, MDUF230356, MDUF230357, MDUF230358, MDUF230359, MDUF230360, MDUF230367, MDUF230368, MDUF230369, MDUF230370, MDUF230371, MDUF230372, MDUF230373, MDUF230374, MDUF230375, MDUF230376, MDUF230377, MDUF230379, MDUF230380, MDUF230381, MDUF230382, MDUF230383, MDUF230384, MDUF230385, MDUF230386, MDUF230387, MDUF230388, MDUF230389, MDUF230390, MDUF230391, MDUF230392, MDUF230393, MDUF230394, MDUF230395, MDUF230396, MDUF230397, MDUF230398, MDUF230399, MDUF230400, MDUF230401, MDUF230402, MDUF230404, MDUF230405, MDUF230406, MDUF230407, MDUF230408, MDUF230409, MDUF230410, MDUF230414, MDUF230417, MDUF230418, MDUF230419, MDUF230420, MDUF230421, MDUF230422, MDUF230423, MDUF230424, MDUF230425, MDUF230426, MDUF230427, MDUF230428, MDUF230429, MDUF230430, MDUF230431, MDUF230432, MDUF230433, MDUF230434, MDUF230435, MDUF230436, MDUF230437, MDUF230438, MDUF240001, MDUF240002, MDUF240003, MDUF240004, MDUF240005, MDUF240006, MDUF240007, MDUF240008, MDUF240009, MDUF240012, MDUF240013, MDUF240014, MDUF240015, MDUF240016, MDUF240017, MDUF240018, MDUF240019, MDUF240020, MDUF240021, MDUF240022, MDUF240024, MDUF240025, MDUF240026, MDUF240027, MDUF240028, MDUF240029, MDUF240030, MDUF240031;

Quantity Affected: 408 units

Reason for Recall

Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-02-27

Company