LaseMD LEO Laser System

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November 12, 2019 Lutronic Global James Childs Clinical Science Director 19 Fortune Drive Billerica, Massachusetts 01821 Re: K192331 Trade/Device Name: LaseMD LEO Laser System 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: September 11, 2019 Received: September 13, 2019 Dear James Childs: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ ce determination does not mean that FDA 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192331 Device Name LaseMD LEO Laser System Indications for Use (Describe) The LaseMD LEO Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots) and ephelides (freckles). | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------|---------------------------------------------------------------------------| | <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K192331 # 510(k) Summary for the Lutronic Corporation LASEMD LEO Laser System This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92. | 1. General Information | | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | Lutronic Corporation<br>219, Sowon-ro<br>Haengsin-dong, Deogyang-gu<br>Goyang-si, Gyeonggi-do, 410-722<br>Republic of Korea<br>Tel: (82) 31-908-3440<br>Fax: (82) 31-907-3440 | | Contact Person: | James Childs<br>Clinical Science Director<br>Lutronic Global<br>19 Fortune Drive<br>Billerica, MA 01821<br>Tel: 978-584-3464<br>Email: jchilds@lutronic.com | | Summary Preparation Date: | August 23, 2019 | | 2. Names | | | Trade Name: | LASEMD LEO Laser System | | Common Name: | Dermatology Laser | | Classification Name: | Laser instrument, Surgical,<br>Powered | | | Product Code: GEX<br>Panel: General and Plastic | # 3. Predicate Devices The LASEMD Laser System and Fraxel DUAL Laser System are surgical instruments for performing dermatological procedures in the treatment of actinic keratosis and treatment of benign pigmented lesions. Surgery {4}------------------------------------------------ | 510(K) Number | K171009 | K130193 | |---------------------------|--------------------------------------|---------------------------------------| | Company Name | Lutronic Corporation | Solta Medical, Inc. | | Device Name | LASEMD Laser System | Fraxel DUAL 1550/1927<br>Laser System | | Classification Regulation | 21 CFR § 878.4810 | 21 CFR § 878.4810 | | Classification Name | Powered Laser Surgical<br>Instrument | Powered Laser Surgical<br>Instrument | | Product Code | GEX | GEX | | Device Panel | General & Plastic Surgery | General & Plastic Surgery | ## 4. Device Description The LaseMD LEO Laser System is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LCD touch screen gives the user control over the necessary laser system parameters. The LaseMD LEO Laser System is equipped with a 658 nm aiming beam. ## 5. Indications for Use The LaseMD LEO Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots) and ephelides (freckles). ## 6. Substantial Equivalence The LaseMD LEO Laser System offers the user the same wavelength, same pulse energy range, same optical train, similar spot sizes, same spot fluence settings and similar per-pass treatment density range as the legally marketed Solta Medical Fraxel DUAL Laser System that is the subject of 510(k) K130193, and LASEMD Laser System (K171009) legally marketed by Lutronic Corporation. The subject and the predicate devices also all operate in pulsed-power mode. The pulsed power setting is user selectable in Expert Mode between 1 – 20W. The maximum power of 20W with the LaseMD LEO system is greater than the maximum pulsed powers available in the predicate devices and is for user convenience. The peak power densities (W/cm2) remain substantially below the ablation threshold and the mechanism of action - thermal coagulation -- is identical to that of the predicate devices. Further, an Animal Study report is included in the submission that establishes equivalence between LaseMD LEO in Energy mode (20W) with the Fraxel Dual device (12W) at similar energy settings. In addition, the LaseMD LEO system operating at 5W or {5}------------------------------------------------ lower power settings is identical in design and performance to the LaseMD system at the same power and energy settings. The C5 tip with 350 um spot size provides fluences within the range of the predicate devices. Further, the shot density of the C5 tip includes 144 mB/cm2 and 225 mB/cm2 shot density settings. The shot density of the Predicate device is up to 426 MTZ/cm². At 20 mJ beam energy treatment, the maximum average shot area energy density (J/cm2) for C5 is 0.02 J x 144 mB/cm2 = 2.88 J/cm² and 0.02 J x 225 mB/cm² = 4.5 J/cm² for the 144 mB/cm² and 225 mB/cm2 shot densities, respectively. The average shot area energy density for the Predicate device at the same beam energy is up to 0.02 J x 426 MTZ/cm2 = 8.52 J/cm². Therefore the C5 tip average shot energy density settings are within those of the Predicate device and do not raise any new concerns about safety. No new concerns about effectiveness arise with the 144 mB/cm2 and 225 mB/cm2 shot densities because they are greater than the densities of the cleared Predicate device with 100 mB/cm2 (comparing the square tip in Stamping mode). Final treatment coverage is also controlled by the number of passes and is the same as those of the predicate devices. Therefore, the technological differences between the subject device and the predicate devices are considered to be minor and no new concerns for safety or effectiveness arise. | Device | LaseMD LEO Laser<br>System | Fraxel DUAL<br>1550/1927<br>Laser System | LASEMD Laser System | |-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | To be assigned | K130193 | K171009 | | Indications for Use | The LaseMD LEO Laser<br>System is indicated for<br>use in dermatological<br>procedures requiring the<br>coagulation of soft<br>tissue, treatment of<br>actinic keratosis, and<br>treatment of benign<br>pigmented lesions such<br>as, but not limited to<br>lentigos (age spots),<br>solar lentigos (sun spots)<br>and ephelides (freckles). | The Fraxel 1927 nm<br>laser is indicated for use<br>in dermatological<br>procedures requiring the<br>coagulation of soft<br>tissue, treatment of<br>actinic keratosis, and<br>treatment of benign<br>pigmented lesions such<br>as, but not limited to<br>lentigos (age spots),<br>solar lentigos (sun spots)<br>and ephelides (freckles). | The LASEMD Laser<br>System is indicated for<br>use in dermatological<br>procedures requiring the<br>coagulation of soft<br>tissue, treatment of<br>actinic keratosis, and<br>treatment of benign<br>pigmented lesions such<br>as, but not limited to<br>lentigos (age spots),<br>solar lentigos (sun spots)<br>and ephelides (freckles). | | Classification | GEX, 21 CFR §<br>878.4810 | GEX, 21 CFR §<br>878.4810 | GEX, 21 CFR §<br>878.4810 | | Laser Type | Thulium laser | Thulium laser | Thulium laser | | Laser Wavelength | 1927 nm | 1927 nm | 1927 nm | | Aiming Beam | 658 nm ≤ 5 mW | 658 nm ≤ 5 mW | 658 nm ≤ 5 mW | | Beam Delivery | Fiber and Handpiece | Fiber and Handpiece | Fiber and Handpiece | | Emission Control | Footswitch | Footswitch | Footswitch | | Display Screen | Yes | Yes | Yes | | Power | 20 W | 12 W | 5 W | | Max Pulse Energy | 20 mJ | 20 mJ | 20 mJ | | Max Pulse Width | 20 ms | 10 ms | 20 ms | | Pulse Repetition Rate | C1 Tip: 43 -323 Hz<br>C5 Tip: 46 - 632 Hz | 0 – 3 kHz | 43.5 – 307.7 Hz | | Laser Beam Spot Size<br>(Spot Fluence Range)<br>[Treatment Method] | 200 µm (All C1 Tips)<br>(3 - 60 J/cm²)<br>[Stamping or Rolling]<br>350 µm (C5 Tip)<br>(1 – 20 J/cm²)<br>[Stamping] | 200 µm (All Tips)<br>(3 - 60 J/cm²)<br>[Rolling] | 100 µm (Cap 100)<br>(12 - 240 J/cm²)<br>[Stamping or Rolling]<br>200 µm (Cap200)<br>(3 - 60 J/cm²)<br>[Stamping] | | Rolling Tx Tips<br>Function:<br>Scan Area/Shot<br>Density<br>Pulses/Shot<br>Shot Energy Range | C1 with Rollers<br>Random:<br>2.5 mm x 10 mm<br>Density 40 mB/cm²<br>(10 Pulses per shot)<br>10 - 200 mJ<br>Dynamic:<br>2 mm x 10 mm<br>Density 25 mB/cm²<br>(5 Pulses per shot):<br>5 - 100 mJ<br>CW:<br>4 mm x 10 mm<br>Density 100 mB/cm²<br>(40 Pulses per Shot)<br>40 - 800 mJ | Small tip: 7 mm<br>(Max at least 426<br>MTZ/cm²)<br>Large tip: 15 mm<br>(Max at least 426<br>MTZ/cm²) | Caps 100, 200<br>Random:<br>2.5 mm x 10 mm<br>Density 40 mB/cm²<br>(10 Pulses per shot)<br>10 - 200 mJ<br>Dynamic:<br>2 mm x 10 mm<br>Density 25 mB/cm²<br>(5 Pulses per shot):<br>5 - 100 mJ<br>CW:<br>4 mm x 10 mm<br>Density 100 mB/cm²<br>(40 Pulses per Shot)<br>40 - 800 mJ | | Stamping Tx Tips<br>Function:<br>Shot Area<br>Density<br>Pulses/Shot<br>Shot Energy Range | C1 (Square, Comb Tip)<br>Static:<br>4 mm x 10 mm<br>Density: 100 mB/cm²<br>(40 Pulses per Shot)<br>40 - 800 mJ<br><br>C5 Tip<br>Static: | Not Applicable | C1 (Square, Comb<br>Tip)<br>Static:<br>4 mm x 10 mm<br>Density: 100 mB/cm²<br>(40 Pulses per Shot)<br>40 - 800 mJ | | | | | | | | 6 mm x 10 mm<br>Density 100 mB/cm2<br>(60 Pulses per Shot):<br>60 – 1200 mJ | | | | | 6 mm x 10 mm<br>Density 144 mB/cm2<br>(84 Pulses per Shot):<br>84 – 1680 mJ | | | | | 6 mm x 10 mm<br>Density 225mB/cm2<br>(135 Pulses per Shot):<br>135 – 2700 mJ | | | | Dimensions of Laser<br>Console | 460 mm (W) x 613 mm<br>(L) x 1744 mm (H) | 489 mm (W) x 451 mm<br>(L) x 444.5 mm (D) | 413 mm (W) x 324 mm<br>(L) x 255.5 mm (D) | | Weight of Laser System | 33kg | 33.1kg | 33.1 kg | | Electrical Rating | AC 100-240 V (Fuse<br>AC250V/6.3A), 50/60<br>Hz, Power consumption | AC 100-240V, 50/60<br>Hz, Power<br>Consumption | AC 100-240V, 50/60<br>Hz, Power<br>Consumption | {6}------------------------------------------------ {7}------------------------------------------------ # 7. Performance Data The Company's performance data for the LASEMD LEO Laser System is as follows: An Animal Study Report is included to demonstrate the equivalence between the C1 tip of the Subject device and the Predicate devices. ## Bench Testing The LASEMD LEO Laser System complies with all applicable standards, including ISO 13485:2016, ISO 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility. See in Appendix 7. ## 8. Conclusion The intended use of the LASEMD LEO Laser System is virtually identical to the intended use of the predicate devices and the technological characteristics of the LASEMD LEO Laser System. Any differences between the LASEMD LEO Laser System and the predicate devices have no significant influence on safety or effectiveness of the LASEMD LEO {8}------------------------------------------------ Laser System. Therefore, the LASEMD LEO Laser System is substantially equivalent to the predicate devices.