DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 15, 2017 Alma Lasers LTD Rekha Anand Regulatory Associate Halamish St Pob 3021 Industrial Park Caesarea, 3088900 Il Re: K170850 Trade/Device Name: Alma Q Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: March 21, 2017 Received: March 22, 2017 Dear Rekha Anand: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Page 2 - Rekha Anand K170850 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device- related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely,, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH ANDHUMAN SERVICES FormApproved:OMBNo. 0910-0120 FoodandDrugAdministration ExpirationDate:January31,2017 Indications for Use SeePRAStatementbelow. 510(k)Number(if known) (cid:44)(cid:18)(cid:24)(cid:17)(cid:25)(cid:22)(cid:17) DeviceName Alma Q Laser Indications for Use (Describe) The Alma Q laser isintended for use inaesthetic(cid:3)and surgical applications requiring the ablation, vaporization,excision, incision, and photothermolysis (photocoagulation orcoagulation)ofsoft tissue inthe medical specialties of dermatology, general and plastic surgery. a)LP1064nm 1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas,warts,telangiectasia,rosacea,venuslake,legveins,andspiderveins. 2. TheAlmaQlasersystemisalsoindicatedforthetreatmentofwrinkles. 3. The Alma Q is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitisbarbae(PFB). 4. TheAlmaQlasersystemisindicatedforuseonallskintypes(FitzpatrickIVI),includingtannedskin. 5. TheintendeduseoftheintegralcoolingsystemintheAlmaQlaserhandpieceistoprovidecoolingof the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potentialsideeffectsoflasertreatments. b)QS532nm 1. Tattooremoval -Redinks -Blueandlightblueinks -Greeninks 2. Treatmentof(cid:69)(cid:72)(cid:81)(cid:76)(cid:74)(cid:81)(cid:3)(cid:89)ascular(cid:79)esions -(cid:55)(cid:72)(cid:79)(cid:68)(cid:81)(cid:74)(cid:76)(cid:72)(cid:70)(cid:87)(cid:68)(cid:86)(cid:76)(cid:68)(cid:86) (cid:16)Spider angiomas -Cherry angiomas -Spider nevi 3. Treatmentof(cid:69)(cid:72)(cid:81)(cid:76)(cid:74)(cid:81)(cid:3)(cid:83)igmented(cid:79)esions -Cafe-au-lait birthmarks (cid:86)olar lentigines -Solar lentigines -Becker's nevi -Freckles -Nevus spilus -Nevus ofota 4. Incision, excision, ablation, and vaporization ofsoft tissue ingeneral dermatology FORMFDA3881(8/14) Page 1 of 3 PSCPublishingServices(301)443-6740 EF c) QS1064nm The Alma Q laser treatment system is intended for use: For the removal or lightening of unwanted facial or body hair. For skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, (cid:37)(cid:72)(cid:81)(cid:76)(cid:74)(cid:81)(cid:3)(cid:71)ermal pigmented lesions (dermal melanocytosis); and For tattoo removal (dark and blue inks). TypeofUse(Selectoneor both,asapplicable) PrescriptionUse (Part 21 CFR801 SubpartD) Over-The-CounterUse(21CFR801SubpartC) CONTINUEONASEPARATEPAGEIFNEEDED. Thissectionappliesonly torequirementsof thePaperworkReduction Act of 1995. *DONOTSENDYOURCOMPLETEDFORMTOTHEPRASTAFFEMAILADDRESSBELOW.* Theburdentimeforthiscollectionof informationisestimated toaverage79 hoursperresponse,includingthe timetoreviewinstructions,searchexistingdatasources,gatherand maintainthedataneededandcomplete and reviewthecollectionofinformation.Sendcommentsregardingthisburdenestimateoranyotheraspect of thisinformationcollection,includingsuggestionsforreducingthisburden,to: Department ofHealthand HumanServices FoodandDrugAdministration OfficeofChiefInformationOfficer PaperworkReductionAct(PRA)Staff [email protected] “Anagencymaynot conductorsponsor,andapersonis notrequiredtorespondto,acollectionof information unless itdisplays acurrentlyvalidOMBnumber.” FORMFDA3881(8/14) Page 2 of 3 Section 8 510(k) Summary A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 I. Submitter Information[21CFR807.92(a) (1)] Owner Name Alma Lasers Inc. Address 485 Half Day Rd. Suite 100 Buffalo Grove, IL 60089 Contact Person Kathy Maynor Regulatory Consultant Email : [email protected] Phone: 352-586-3113 Summary Preparation Date March 21, 2017 II. Name of device [21 CFR807.92(a) (2)] Trade or Proprietary Name Alma Q Laser Common Device Name(s) and Product Classification Panel Regulation Regulatory Class Code(s) § 878.4810, Laser surgical General & Plastic Laser Powered Surgical GEX Surgery Panel, 79 (SU) instrument for use in general and Instruments (& Accessories) plastic surgery and dermatology Class II Surgical Powered Lasers and Delivery Devices/Hand piece Accessories III. Predicate Devices [21 CFR807.92(a) (3)] 510(k) # Trade Name Product Code K040384 Mydon/Quantel Derma GEX K032667 Naturalase/Focus Medical GEX K992597 Naturalase/Focus Medical GEX IV. Device Description [21CFR807.92(a)(4)] The subject device, Alma Q Laser incorporates a flash lamp pumped Nd:Yag laser. The radiation emitted by this device has the ideal 1064nm wavelength. It also incorporates a built-in frequency conversion technology to obtain the 532nm (green) wavelength. The laser system is operated with an articulated arm system for transmitting the laser radiation with different size tips. Alma Q can operate in Q-switching mode and produce 1064nm wavelength beam. This Premarket Notification, Traditional 510(k) Section 8: Page 1 The Alma Q Laser beam can also be efficiently converted into 532nm wavelength beam using a KTP crystal. This laser can also operate in long-pulsed mode at 1064nm wavelength. The system is intended to be used in user facilities such as hospitals, physicians’ offices and medical spas. The material that could contact the patient during device use is aluminum with limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling. V. Intended use of deviceandIndications forUse [21CFR807.92(a) (5)] The Alma Q laser is intended for use in aesthetic and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery. The indications for use for the Alma Q laser share the same or similar indications for use as the predicate devices in that: LP1064nm 1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins. 2. The Alma Q laser system is also indicated for the treatment of wrinkles. 3. The Alma Q is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB). 4. The Alma Q laser system is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin. 5. The intended use of the integral cooling system in the Alma Q laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments. QS 532nm 1. Tattoo removal -Red inks -Blue and light blue inks -Green inks 2. Treatment of benign vascular lesions -Telangiectasias -Spider angiomas -Cherry angiomas -Spider nevi 3. Treatment of benign pigmented lesions -Cafe-au-lait birthmarks -Solar lentigines -Becker's nevi -Freckles Premarket Notification, Traditional 510(k) Section 8: Page 2 The Alma Q Laser -Nevus spilus -Nevus of ota 4. Incision, excision, ablation, and vaporization of soft tissue in general dermatology QS 1064nm The Alma Q laser treatment system is intended for use: For the removal or lightening of unwanted facial or body hair. For skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, Benign dermal pigmented lesions (dermal melanocytosis); and For tattoo removal (dark and blue inks). VI. Summary of technological characteristics of the device compared to the predicate[21 CFR 807.92(a)(6)] The technological principles underlying the subject and the predicate devices are the same. A table comparing the key features of the subject and predicate devices is provided on the following page. Premarket Notification, Traditional 510(k) Section 8: Page 3 The Alma Q Laser Alma Q LP 1064nm Substantial Equivalence Table Characteristi Alma Q Mydon c (K040384) Wavelength 1064nm 1064nm Output energy 40J 40J Fluence 10-450J/cm2 10-450J/cm2 3.0mm spot = 30-300J/cm2 1.5mm spot = 160-450 J/cm2 5mm spot = up to 240 J/cm2 3.0mm spot = 30-300J/cm2 7mm spot = 15-100 J/cm2 5mm spot = up to 240 J/cm2 8mm collimated = up to 58J/cm2 7mm spot = 15-100 J/cm2 10mm spot = 15-50 J/cm2 Pulse duration 0.5 – 60ms 0.5 to 90 ms Repetition 1,2,3, 5 for LP Single shot to 10Hz rate Delivery Removable tips Permanently attached handpiece with inserts system Spot size 3,5,7,8mm 1.5-10mm Aiming beam red red Footswitch Yes Yes Console 176 cm x 29 cm x 86 cm (top Not known dimensions height of articulated arm) (66.3" x 11.42" x 34") Weight 75 kg. / 165.4 lbs. Not known Indications For the coagulation and For the coagulation and hemostasis of benign for Use hemostasis of benign vascular vascular lesions such as, but not limited to, port lesions such as, but not limited wine stains, hemangiomas, warts, telangiectasia, to, port wine stains, rosacea, venus lake, leg veins, and spider veins. hemangiomas, warts, 2. The MYDON C laser system is also indicated telangiectasia, rosacea, venus for the treatment of wrinkles. 3. The MYDON C lake, leg veins, and spider veins. is also indicated for the removal of unwanted hair 2. The Alma Q laser system is and for the treatment of pseudofolliculitis barbae also indicated for the treatment (PFB). 4. The MYDON C laser system is of wrinkles. 3. The Alma Q is indicated for use on all skin types (Fitzpatrick also indicated for the removal of IVI), including tanned skin. 5. The intended use unwanted hair and for the of the integral cooling system in the MYDON C treatment of pseudofolliculitis laser handpiece is to provide cooling of the skin barbae (PFB). 4. The Alma Q prior to laser treatment, for the reduction of pain laser system is indicated for use during laser treatment, to allow for the use of on all skin types (Fitzpatrick higher fluences for laser treatments such as hair IVI), including tanned skin. 5. removal and vascular lesions, and to reduce the The intended use of the integral potential side effects of laser treatments. cooling system in the Alma Q laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and benign vascular lesions, and to reduce the potential side effects of laser treatments. Premarket Notification, Traditional 510(k) Section 8: Page 4 Alma Q Laser Alma Q QS 1064nm Substantial Equivalence Table Characteristic Alma Q Naturalase K992597 Laser QS 1064nm QS 1064nm wavelength Pulse width 7ns (6-8ns) Light source Solid state Solid state Repetition (Hz) 1,2,5,10 Hz 1,2,5,10 Hz Max Output 1800mJ 1800mJ energy Fluence 2mm – 57.32 J/cm2 2mm – 57.32 J/cm2 3mm – 25.5 J/cm2 3mm – 25.5 J/cm2 4mm - 14.3 J/cm2 4mm –14.3 J/cm2 5mm – 9.17 J/cm2 5mm – 9.17 J/cm2 6mm - 6.4 J/cm2 6mm – 6.4 J/cm2 7mm - 4.7 J/cm2 7mm –4.7 J/cm2 8mm - 3.6 J/cm2 8mm – 3.6 J/cm2 9mm – NA 10mm - NA Spot Size 3-7mm 3 – 10mm 8mm collimated Operation mode Single shot, continuous Single shot Aiming beam Red. Variable intensity red Footswitch Yes Yes Premarket Notification, Traditional 510(k) Section 8: Page 5 Alma Q Laser Characteristic Alma Q Naturalase K992597 Console 176 cm x 29 cm x 86 cm (top 124cm x 43cm x 66cm dimensions height of articulated arm) (66.3" x 11.42" x 34") (50ʺ x 17ʺ x 27ʺ)  Weight 75 kg. / 165.4 lbs 125Kg./275lbs. Articulated arm Yes Yes Electrical 230 VAC, 13A, 50/60 Hz, AC 230 V, 50/60 Hz requirements single phase Indications for The Alma Q laser The Lorad LT-100 laser Use treatment system is treatment system is intended intended for use: for use: For the removal or lightening Alone or in conjunction with of unwanted facial or body an adjuvant lotion for the hair. removal or lightening of unwanted facial or body hair. One or two treatments may be required for lightening or removing unwanted hair For skin resurfacing without the adjuvant lotion; (ablation of epidermal skin layers) in dermatology and aesthetic surgery, In combination with the adjuvant lotion for skin Dermal benign pigmented resurfacing (ablation of lesions (dermal epidermal skin layers) in melanocytosis); and dermatology and aesthetic surgery, For tattoo removal (dark and blue inks). Dermal pigmented lesions (dermal melanocytosis); and For tattoo removal (dark and blue inks). The adjuvant lotion is a suspension of carbon powder in a base of Light Mineral Oil, NF Premarket Notification, Traditional 510(k) Section 8: Page 6 Alma Q Laser