LN/NH: 2011/07/18. Device Class/Classe de l'instrument: 2. Licence Name/Nom de l'homologation: EVO HANDPIECE. Licence Type/Type d'homologation:

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2 Santé Health Canada Canada LN/NH: Therapeutic Products Directorate Medical Devices Bureau Direction des produits thérapeutiques Bureau des matériels médicaux Medical Device Licence Homologation d'un instrument médical Licence Number: First Issue Date: /07/18 No d'homologation: Première date de délivrance: Device Class/Classe de l'instrument: 2 This Licence is issued in accordance with the Medical Devices Regulations, Section 36, for the following medical device: La présente homologation est délivrée en vertu de l'article 36 du Règlement sur les instruments médicaux pour l'instrument médical suivant: Licence Name/Nom de l'homologation: EVO HANDPIECE Licence Type/Type d'homologation: Family / Famille Manufacturer Name & Address/Nom du fabricant & adresse MEDICAM INC JEAN BRILLON MONTREAL, QUEBEC CANADA H8N 2L5 Application Number: Numéro de la demande: Manufacturer ID: Identificateur du fabricant:

3 Santé Health Canada Canada LN/NH: Therapeutic Products Directorate Medical Devices Bureau Direction des produits thérapeutiques Bureau des matériels médicaux Components/Parts/Accessories/Devices for this Licence Les composantes, parties, accessoires et instruments médicaux pour cette homologation EVO HANDPIECE Device ID/No de l'instrument: Device Identifier / Identificateur de l'instrument (Model/Catalog Detail/No de modèle/catalogue): HP-EVO-4 HP-EVO-4B Application Number: Numéro de la demande: Page 2 Manufacturer ID: Identificateur du fabricant:

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5 Santé Health Canada Canada LN/NH: Therapeutic Products Directorate Medical Devices Bureau Direction des produits thérapeutiques Bureau des matériels médicaux Medical Device Licence Homologation d'un instrument médical Licence Number: First Issue Date: /07/18 No d'homologation: Première date de délivrance: Device Class/Classe de l'instrument: 2 This Licence is issued in accordance with the Medical Devices Regulations, Section 36, for the following medical device: La présente homologation est délivrée en vertu de l'article 36 du Règlement sur les instruments médicaux pour l'instrument médical suivant: Licence Name/Nom de l'homologation: EVOLUX HANDPIECE Licence Type/Type d'homologation: Family / Famille Manufacturer Name & Address/Nom du fabricant & adresse MEDICAM INC JEAN BRILLON MONTREAL, QUEBEC CANADA H8N 2L5 Application Number: Numéro de la demande: Manufacturer ID: Identificateur du fabricant:

6 Santé Health Canada Canada LN/NH: Therapeutic Products Directorate Medical Devices Bureau Direction des produits thérapeutiques Bureau des matériels médicaux Components/Parts/Accessories/Devices for this Licence Les composantes, parties, accessoires et instruments médicaux pour cette homologation EVOLUX HANDPIECE Device ID/No de l'instrument: Device Identifier / Identificateur de l'instrument (Model/Catalog Detail/No de modèle/catalogue): HP-EVOLUX V4G HP-EVOLUX V4P Application Number: Numéro de la demande: Page 2 Manufacturer ID: Identificateur du fabricant:

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8 Santé Health Canada Canada LN/NH: Therapeutic Products Directorate Medical Devices Bureau Direction des produits thérapeutiques Bureau des matériels médicaux Medical Device Licence Homologation d'un instrument médical Licence Number: First Issue Date: /07/18 No d'homologation: Première date de délivrance: Device Class/Classe de l'instrument: 2 This Licence is issued in accordance with the Medical Devices Regulations, Section 36, for the following medical device: La présente homologation est délivrée en vertu de l'article 36 du Règlement sur les instruments médicaux pour l'instrument médical suivant: Licence Name/Nom de l'homologation: EVOLASE HANDPIECE Licence Type/Type d'homologation: Family / Famille Manufacturer Name & Address/Nom du fabricant & adresse MEDICAM INC JEAN BRILLON MONTREAL, QUEBEC CANADA H8N 2L5 Application Number: Numéro de la demande: Manufacturer ID: Identificateur du fabricant:

9 Santé Health Canada Canada LN/NH: Therapeutic Products Directorate Medical Devices Bureau Direction des produits thérapeutiques Bureau des matériels médicaux Components/Parts/Accessories/Devices for this Licence Les composantes, parties, accessoires et instruments médicaux pour cette homologation EVOLASE HANDPIECE Device ID/No de l'instrument: Device Identifier / Identificateur de l'instrument (Model/Catalog Detail/No de modèle/catalogue): HP-EVO-4L Application Number: Numéro de la demande: Page 2 Manufacturer ID: Identificateur du fabricant:

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14 Certificate of Registration The following organization s quality management system has been assessed and registered by Intertek Testing Services NA Ltd., a CMDCAS recognized registrar, as conforming to the requirements of: ISO 13485:2003 Organization: Certificate Number MED Initial Certification Date October 1, 2010 Medicam Inc. Main Site: 7900 Jean-Brillon, Montréal, Québec, H8N 2L5, Canada Certificate Effective Date November 17, 2010 Certificate Expiry Date October 1, 2013 The Quality Management System is applicable to: Design, manufacturing and repair of aesthetic and medical equipments using pulsed light. In the issuance of this certificate, Intertek assumes no liability to any party other than to the Client, and then only in accordance with the agreed upon Certification Agreement. GF106-CA-CMDCAS Issue Date 01/05/2008 David S. Muil General Manager - Canada Intertek Testing Services NA Ltd. Lachine, QC, Canada

15 Certificat d enregistrement Le système de management de la qualité de l organisme suivant a été audité et enregistré par les Services d essais Intertek AN ltée, Un registraire reconnu SCECIM, et jugé conforme aux exigences de la norme ISO 13485:2003 Numéro de certificat MED Date de certification initiale 1 octobre 2010 Date d entrée en vigueur 17 novembre 2010 Date d expiration du certificat 1 octobre 2013 Organisme : Medicam Inc. Site principal: 7900 Jean-Brillon, Montréal, Québec, H8N 2L5, Canada Le système de management de la qualité s applique aux activités suivantes : Conception, fabrication et réparation d équipements à lumière pulsée utilisés à des fins médicales et esthétiques. Intertek n assume aucune responsabilité envers les tierces parties quant à l émission de ce certificat conformément aux clauses définies dans l entente de certification. GF106-CA-CMDCAS-FR Issue Date 01/05/2008 David S. Muil Directeur Général - Canada Services d essais Intertek AN ltée Lachine, QC, Canada

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17 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service U.S. Food and Drug Administration Center for Devices and Radiological Health Document Control Center WO66-G New Hampshire Avenue Silver Spring, MD May 13, 2011 AMAR PHILIPPE MEDICAM INC JEAN-BRILLON MONTREAL, QUEBEC CANADA H8N 2L5 ATTN: PHILIPPE AMAR 510k Number: K Received: 5/13/2011 Product: MEDICAM EVOLUX, EVOSTAR, EVOLIGHT, EVOLASE The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), has received the Premarket Notification, (510(k)), you submitted in accordance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act (Act) for the above referenced product and for the above referenced 510(k) submitter. Please note, if the 510(k) submitter is incorrect, please notify the 510(k) Staff immediately. We have assigned your submission a unique 510(k) number that is cited above. Please refer prominently to this 510(k) number in all future correspondence that relates to this submission. We will notify you when the processing of your 510(k) has been completed or if any additional information is required. Please remember that all correspondence concerning your submission MUST be sent to the Document Mail Center (DMC) at the above letterhead address. Correspondence sent to any address other than the one above will not be considered as part of your official 510(k) submission. If you have procedural questions, please contact the 510(k) Staff at (301) Sincerely, 510(k) Staff

18 510(k) Premarket Notification Device Classification Name powered light based non-laser surgical instrument with thermal effect 510(K) Number K Model EVOLUX V4110, EVOLIGHT V4110, EVOSTAR V4110, EVOLASE V4110 Device Name MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM Applicant MEDICAM INC jean-brillon montreal, quebec, Contact philippe amar Regulation Number Classification Product ONF Code Date Received 05/13/2011 Decision Date 09/29/2011 Decision substantially equivalent (SE) Classification Advisory Committee General & Plastic Surgery Review Advisory Committee General & Plastic Surgery summary summary Type Traditional Reviewed by Third Party No Expedited Review No Combination Product No

19 CFR-CodeofFederalRegulationsTitle21 [CodeofFederalRegulations] [Title21,Volume8] [RevisedasofApril1,2011] [CITE:21CFR ] SubpartE-SurgicalDevices TITLE21-FOODANDDRUGS CHAPTERI-FOODANDDRUG ADMINISTRATION DEPARTMENTOFHEALTHANDHUMANSERVICES SUBCHAPTERH-MEDICALDEVICES PART878 -GENERALANDPLASTICSURGERYDEVICES Sec Lasersurgicalinstrumentforuseingeneralandplasticsurgeryandindermatology. (a)identification.(1)acarbondioxidelaserforuseingeneralsurgeryandindermatologyisalaserdeviceintendedtocut,destroy,orremovetissue bylightenergyemitedbycarbondioxide. (2)Anargonlaserforuseindermatologyisalaserdeviceintendedtodestroyorcoagulatetissuebylightenergyemitedbyargon. (b)classification.(1)classi. (2)ClassIforspeciallasergasmixturesusedasalasingmedium forthisclassoflasers.thedevicessubjecttothisparagraph(b)(2)areexempt from thepremarketnotificationproceduresinsubparteofpart807ofthischapter,subjecttothelimitationsin [53FR23872,June24,1988,asamendedat61FR1123,Jan.16,1996;66FR38803,July25,2001]