<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00816722021625</udiDi>
    <basicUdiDi>00816722021600DC</basicUdiDi>
    <tradeName>enlighten SR</tradeName>
    <deviceName>enlighten Family</deviceName>
    <manufacturerName>Cutera, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010456</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENLIGHTENSR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:23:03.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816722021311</udiDi>
    <basicUdiDi>00816722021300CV</basicUdiDi>
    <tradeName>excel V+</tradeName>
    <deviceName>excel Family</deviceName>
    <manufacturerName>Cutera, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010456</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EXCELV+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:23:02.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-11101CLV</udiDi>
    <basicUdiDi>B-11101CLV</basicUdiDi>
    <tradeName>D-11101CLV</tradeName>
    <deviceName>Long-pulsed Alexandrite+Nd:YAG Laser</deviceName>
    <manufacturerName>Lutronic Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000009035</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLARITY LPC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:47:35.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771815</udiDi>
    <basicUdiDi>729011777OPTN8</basicUdiDi>
    <tradeName>OptiLight System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA-0005500Be</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:09.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117772768</udiDi>
    <basicUdiDi>729011777QSWHPKU</basicUdiDi>
    <tradeName>Stellar M22™ Q-Switched Nd:YAG Upgrade Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UGAC-20109600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:09.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771778</udiDi>
    <basicUdiDi>729011777OPTHPJ2</basicUdiDi>
    <tradeName>OPT Module Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-2012586Be</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:09.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771785</udiDi>
    <basicUdiDi>729011777OPTHPJ2</basicUdiDi>
    <tradeName>OptiLight IPL Handpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-2011950-OPTBe</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:08.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771914</udiDi>
    <basicUdiDi>729011777OPTHPJ2</basicUdiDi>
    <tradeName>OptiLight IPL Handpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-20106870-OPTBe</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:08.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117772751</udiDi>
    <basicUdiDi>729011777YAGHPG6</basicUdiDi>
    <tradeName>Stellar M22™ Multi-Spot™ Nd:YAG  Upgrade kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UGAC-20109590</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:08.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117772737</udiDi>
    <basicUdiDi>729011777YAGHPG6</basicUdiDi>
    <tradeName>Multi-SpotTM  Nd:YAG Head</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-10202200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:08.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290117771907</udiDi>
    <basicUdiDi>729011777OPTKTJK</basicUdiDi>
    <tradeName>IPL Upgrade Kit for OptiLight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lumenis Be LTD</manufacturerName>
    <manufacturerSrn>IL-MF-000022063</manufacturerSrn>
    <authorisedRepresentativeName>Lumenis (Germany) GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007699</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UG-00024720Be</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:06.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>03830054230125</udiDi>
    <basicUdiDi>3830054230005S9</basicUdiDi>
    <tradeName>XS Dynamis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FOTONA, proizvodnja optoelektronskih naprav d.o.o.</manufacturerName>
    <manufacturerSrn>SI-MF-000000126</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M002-2A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:06.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>03830054230118</udiDi>
    <basicUdiDi>3830054230005S9</basicUdiDi>
    <tradeName>XP Dynamis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FOTONA, proizvodnja optoelektronskih naprav d.o.o.</manufacturerName>
    <manufacturerSrn>SI-MF-000000126</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M001-12F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:05.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>03830054230200</udiDi>
    <basicUdiDi>3830054230005S9</basicUdiDi>
    <tradeName>SP Spectro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FOTONA, proizvodnja optoelektronskih naprav d.o.o.</manufacturerName>
    <manufacturerSrn>SI-MF-000000126</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M021-4AF/3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:05.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>03830054237698</udiDi>
    <basicUdiDi>3830054230004S7</basicUdiDi>
    <tradeName>LightWalker ST-E PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FOTONA, proizvodnja optoelektronskih naprav d.o.o.</manufacturerName>
    <manufacturerSrn>SI-MF-000000126</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M002-6A/2 PRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:01:04.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>03830054230996</udiDi>
    <basicUdiDi>3830054230004S7</basicUdiDi>
    <tradeName>LightWalker ST-E PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FOTONA, proizvodnja optoelektronskih naprav d.o.o.</manufacturerName>
    <manufacturerSrn>SI-MF-000000126</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M002-6A/2 PRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:00:44.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>03830054230514</udiDi>
    <basicUdiDi>3830054230004S7</basicUdiDi>
    <tradeName>TimeWalker ST-E</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FOTONA, proizvodnja optoelektronskih naprav d.o.o.</manufacturerName>
    <manufacturerSrn>SI-MF-000000126</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M002-6A/2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:00:44.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>03830054237704</udiDi>
    <basicUdiDi>3830054230004S7</basicUdiDi>
    <tradeName>LightWalker ST-E ADVANCED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FOTONA, proizvodnja optoelektronskih naprav d.o.o.</manufacturerName>
    <manufacturerSrn>SI-MF-000000126</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M002-6A/2 ADVANCED</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:00:44.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809447655864</udiDi>
    <basicUdiDi>88094476511102AVK</basicUdiDi>
    <tradeName>C type tip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lutronic Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000009035</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLARITY II, CLARITY II LPA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:58:16.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809447655888</udiDi>
    <basicUdiDi>88094476511102AVK</basicUdiDi>
    <tradeName>O Type IntelliTrak tip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lutronic Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000009035</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLARITY II, CLARITY II LPA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:58:15.559Z</lastUpdated>
  </row>
</eudamedExport>