Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION". FineMEC Co., Ltd. Mr. William McGrail Principal McGrail Consulting, LLC 62 Dale Road Meredith, New Hampshire 03253 November 30, 2018 Re: K182663 Trade/Device Name: Nobleen Long Pulsed Alexandrite & Nd: YAG 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 24, 2018 Received: September 25, 2018 Dear William McGrail: 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. 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 {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Neil R.P. Ogden Digitally signed by Neil R.P. Ogden Date: 2018.11.30 11:41:44 -05'00' 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182663 #### Device Name Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System #### Indications for Use (Describe) 755nm The Nobleen Long Pulsed Alexandrite & Nd: Y AG Laser is indicated for temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re growing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). 1064nm The Nobleen Long Pulsed Alexandrite & Nd: YAG Laser is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re growing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea. Venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratosis. nevi, chloasma, verrucae, skin tags, keratos (signi flcant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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." {4}------------------------------------------------ Section 5. 510(k) Summary {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for FineMEC. The logo consists of a stylized symbol on the left and the word "FineMEC" on the right. The symbol is a black shape with curved lines, and the word "FineMEC" is written in a bold, sans-serif font, also in black. 510(k) Summary (As Required by 21.CFR.807.92) - 1. SUBMITTER FineMEC Co., Ltd. Manufacturer: #604-1, 217, Heojun-ro, Gangseo-gu Seoul, Korea 07531 Contact Person: William H. McGrail McGrail Consulting, LLC 62 Dale Road Meredith, NH 03253 Phone: (978) 808-0420 Email: bill(@mcgrailconsulting.com #### Date Prepared: November 28, 2018 ### 2. DEVICE INFORMATION | Trade/Device Name(s): | Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System | |------------------------------|--------------------------------------------------------| | Regulation Number: | 21 CFR § 878.4810 | | Device Classification Name: | Powered Laser Surgical Instrument | | Regulation Class: | Class II | | Classification Product Code: | GEX | | 510k Review Panel: | General & Plastic Surgery | #### 3. PREDICATE DEVICES Candela Corporation, CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS (K133283) Reference Device: FineMEC Co., LTD, Noblex Long Pulse Alexandrite Lase (K143666) {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for FineMEC. The logo consists of a stylized symbol on the left and the word "FineMEC" on the right. The symbol is a black shape with curved lines, and the word "FineMEC" is written in a bold, sans-serif font, also in black. #### 4. DEVICE DESCRIPTION The Nobleen Long pulsed Alexandrite & Nd: Y AG Laser System contains two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 mm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Rapid Cooling System (RCS) protects the upper layers of the skin with a cooling burst of cryogen. #### 5. INDICATIONS FOR USE #### 755mm The Nobleen Long Pulsed Alexandrite & Nd:YAG Laser is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re growing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). #### 1064nm The Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re growing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea. Venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis. nevi, chloasma, verrucae, skin tags, keratosis. tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for FineMEC. The logo consists of a stylized symbol on the left and the word "FineMEC" on the right. The symbol is a black square with a white design inside, and the word "FineMEC" is written in a bold, sans-serif font. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. ## 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System has the same intended use and similar indications for use, technological characteristics and operating principles as the Candela GentleMax Family of Laser System (K133283) predicate. The Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System and the predicate deliver laser energy through an identical 1000 u optical fiber handpiece delivery system, which can output either 755 nm or 1064 nm wavelengths. The output of Nobleen Long Pulsed Alexandrite & Nd:YAG Laser system and the predicate is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch (footswitch) is used to control the delivery of laser pulses for both Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System and the predicate device. The Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System and the predicate both use a short burst of cryogen spray prior to firing the laser pulse to cool the skin. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of laser light on the skin. The cryogen for both Nobleen Long Pulsed Alexandrite & Nd:YAG Laser system and the predicate, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece. ## 7. PERFORMANCE DATA Testing to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC 60825-1 has been conducted on the Nobleen Long Pulsed Alexandrite & Nd: Y AG Laser System. Bench testing has also been performed to show that the performance specifications of Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System is identical to the predicate device. All performance testing demonstrated that the Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System performs according to specifications and functions as intended. The following non-clinical testing was performed on the Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System. These tests verified that the output of the Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System was identical to the predicate device. Electrical Safety and Electromagnetic Compatibility: Electrical safety and electromagnetic compatibility (EMC) testing for the Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System was conducted by an independent test laboratory in accordance with IEC 60601-1, Medical {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for FineMEC. The logo consists of a stylized symbol on the left and the word "FineMEC" in bold, sans-serif font on the right. The symbol appears to be an abstract design, possibly representing interconnectedness or precision. The overall design is clean and modern. electrical equipment, Part 1: General requirements for basic safety and essential performance and with IEC 60601-1-2, Collateral Standard: Electromagnetic Compatibility - Requirements and Tests, 3rd ed. The Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System was determined to be in conformance with applicable IEC standards (IEC 62366, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1). Software: Software verification testing was conducted, and results demonstrated that testing results were found acceptable for software release. Software testing was performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". Bench Testing: A system verification and validation of the Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System was conducted to confirm that the specifications match that of the predicate device. The testing results were found acceptable. #### Clinical Testing Based on the similarities of the device specifications, intended use, indications for use, treatment guidelines between the Nobleen Long Pulsed Alexandrite & Nd: Y A G Laser System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification. #### 8. SUBSTANTIAL EQUIVALENCE The Nobleen Long Pulsed Alexandrite & Nd: Y AG Laser System has the same intended uses. utilizes similar operating principles, and matches key design aspects, including similar spot size, the same wavelengths and the same maximum delivered energy as the predicate device. The nonclinical tests that were performed determined that Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System device is as safe, as effective, and performs as well as the predicate device. On the basis of similarities in methods of assembly, method of operation, and intended uses, as confirmed by the performance testing, FineMEC believes that the Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System is substantially equivalent to the predicate device. #### 9. CONCLUSION The performance testing data demonstrates that Nobleen Long Pulsed Alexandrite & Nd: Y AG Laser System is as safe and effective as the legally marketed predicate devices. Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System did not raise new questions of safety or effectiveness. Therefore, based on the information provided in this Premarket Notification, we conclude that Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System has demonstrated substantial equivalence to the predicate devices.