Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 7, 2022 Sanhe Laserconn Tech Co., Ltd. % Gary Wang Q&R Consultant Bonnier Quality Supervision Consulting (JM) Center Hailunxinyuan No.3203, Jianghai District Jiangmen, Guangdong 529000 China Re: K222800 Trade/Device Name: Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) 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 8, 2022 Received: September 16, 2022 Dear Gary Wang: 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}------------------------------------------------ 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. # Jianting Wang -S Jianting Wang 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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K22800 Device Name Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) #### Indications for Use (Describe) Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Standard-A) is intended for hair removal permanent hair reduction on all skin type 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) --- Over-The-Counter Use (21 CFR 801 Subpart C) #### 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}------------------------------------------------ ## 510(k) Summary Date: 10-21-2022 (M/D/Y) the following summary of information is provided: In accordance to 21 CFR 807.92 regulation, | I Applicant/Manufacturer | Sanhe Laserconn Tech Co., Ltd.<br>X03-A Building, Baishijingu Industry Park, Yanjiao,<br>Langfang, Hebei, China 065201 | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Miss Xia aijiang<br>Phone: (+86) 15726687295<br>E-mail: xiaaijian@laserconn.com | | II Submitter/Correspondent | Bonnier Quality Supervision Consulting (JM) Center<br>Hailunxinyuan No.3203, Jianghai District, Jiangmen City<br>China 529000 | | Contact Person | Mr. Gary Wang<br>Q&R Consultant<br>Phone: (+86)13600366215<br>E-mail: gary.wang@bonnier.net.cn | #### III Device Regulation Information | Common Name of Device: | Powered Laser Surgical Instrument | |----------------------------|-------------------------------------------------------------------------------------------------------| | Classification panel: | General & Plastic Surgery | | Classification Names: | Laser Surgical Instrument for Use in General and Plastic | | | Surgery and In Dermatology | | Regulation Number: | 21 CFR 878.4810 | | Regulation Class: | II | | Product Code: | GEX | | Type of 510(k) submission: | Traditional 510(k) | | Model Name/Number | Milestone Smart-M, Milestone Standard-A | | Device Trade Name | Diode Laser Hair Removal Systems for Medical Use<br>(Models: Milestone Smart-M, Milestone Standard-A) | #### IV Predicate Device Information Predicate Device 1 Sponsor: Device Name: 510(K) Number: Predicate Device 2 Alma Lasers, Inc. SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM K140009 {4}------------------------------------------------ Sponsor: Device Name: 510(K) Number: Beijing Kes Biology Technology CO., LTD. Diode laser therapy system K210168 #### V Device Description Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is solution for fast hair removal with 810nm±10nm high power laser diodes. They are designed with TEC and sapphire cooling unit for skin contact. The laser beam is sublimated with a patented technology of beam shaping for a high efficiency for hair removal solution. This diode laser hair removal can be used for Fitzpatrick skin type I-VI. The pulse energy is up to 40J/cm². #### VI Indications for Use Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type 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. #### VII Compatibility Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) does not connect with any other device and does not connect network during normal operation. So will not cause any problem related to compatibility with other device and network. For EMC, the devices were tested according to IEC 60601-1-2:2014. #### VIII Technological Comparison Pls refer to the later part: Substantial Equivalence Comparison Table 1 #### IX Software Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) includes software which are interface between operator and device. The risk analysis and control to software is done, the Level of Concern is classified as Moderate LOC. The validation to software is done according to FDA Final Guidance-General Principles of Software Validation and confirm the software does not raise unacceptable risk by Sanhe Laserconn Tech Co., Ltd. #### X. Summary of Verification Tests All verification tests have been performed according to below standard, the testing results are passed 1.AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2.IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. 3.ISO 10993-5:2009: Biological evaluation of medical devices. Part 5-Tests for in vitro cytotoxicity. 4.ISO 10993-10:2010 Biological evaluation of medical devices, Part 10-Tests for irritation and skin sensitization. {5}------------------------------------------------ 5.IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements. 6.IEC 60601-2-22:2019 for use in conjunction with AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. 7. Software embedded in medical device was validated by the least burdensome approach according to FDA Final Guidance-General Principles of Software Validation. 8.IEC62304-2015 Medical device software – Software life cycle processes 9.ISO10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management Bench testing was conducted to demonstrate that system operation, wavelength, single pulse laser energy, repetition frequency, laser power output, and cooling parameters met specified requirements. The test results also show that both models Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) have achieved the expected results and satisfied the standards listed above. #### XI.Conclusion: Based on the SE comparison and software validation result, Sanhe Laserconn Tech Co., Ltd. considers Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) does not raise any new issues of safety or effectiveness, and performs as well as the legally marketed predicate device. {6}------------------------------------------------ | Substantial Equivalence Comparison Table 1 | | | | Discussion | |--------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------| | Description | Predicate Device 1 | Predicate Device 2 | Subject Device | | | K number | K140009 | K210168 | K222800 | | | Device name | SOPRANO ICE MULTI-APPLICATION &<br>MULTI-TECHNOLOGY PLATFORM | Diode laser therapy system | Diode Laser Hair Removal Systems for<br>Medical Use (Models: Milestone Smart-M,<br>Milestone Standard-A) | | | Manufacturer | Alma Lasers, Inc. | Beijing Kes Biology Technology CO.,<br>LTD. | Sanhe Laserconn Tech Co., Ltd. | | | Prescription | Yes | Yes | Yes | Same | | Over-the-Counter use | No | No | No | Same | | Product Code | GEX | GEX | GEX | Same | | Configuration | Main console Unit | Main Unit | Main Unit | Same | | | Modules | Handle | Handle | Same | | Laser Type | Diode Laser | Diode Laser | Diode Laser | Same | | Laser Classification | Class IV | Class IV | Class IV | Same | | Regulatory Class | Class II | Class II | Class II | Same | | Wavelength | 810nm(nominal) | 808nm(nominal) | 810nm(nominal) | Discussion 1 | | Spot Size | $12 mm\times10 mm=1.2 cm2$ | $12 mm\times12 mm=1.44 cm2$ | $10 mm\times10 mm=1.0 cm2$ | Discussion 2 | | Fluence | 2-20 J/cm2 (SHR), 2-120 J/cm2 (HR) | 10-125 J/cm2 | 1-40 J/cm2 | Discussion 3 | | Pulse Duration | 3.3-200 ms | 10-400 ms | 3-160 ms | Discussion 4 | | Frequency | 5-10 Hz (SHR), 0.5-3 Hz (HR) | 1-10 Hz | 1-10 Hz | Discussion 5 | | Tissue Cooling | Contact continuous, thermo-electrical | Aluminum contact, close-cycle water cooling | Sapphire Contact and TEC Cooling | Discussion 6 | | Power Supply | Unknown | 99V-121V, 50/60Hz 1400VA | AC 100~240V/50/60Hz 1500VA | Discussion7 | | Biocompatibility | Unknown | Comply with ISO 10993-5, ISO 10993-10 | Comply with ISO 10993-5 ISO 10993-10 | Discussion 8 | | Electrical Safety | Comply with IEC 60601-1,<br>IEC 60601-2-22,<br>IEC 60825-1 | Comply with IEC 60601-1,<br>IEC 60601-2-22,<br>IEC 60825-1 | Comply with IEC 60601-1<br>IEC 60601-2-22<br>IEC 60825-1 | Same | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same | | Storage temperature | Unknown | Unknown | 5°C-55°C | Discussion 9 | | Operation temperature | Unknown | Unknown | 5°C-30°C | Discussion 11 | | Operating humidity | Unknown | Unknown | ≤80% | Discussion 12 | | Dimension | 6.69*4.8*1.9 [inches] | 450×430×1000(mm) | 464*387*979(mm) (Milestone Standard-A)<br>437*355*233(mm) (Milestone Smart-M) | Discussion 13 | | Weight | Unknown | 52kg | 46.1kg (Milestone Standard-A)<br>18.2kg (Milestone Smart-M) | Discussion 14 | {7}------------------------------------------------ #### Discussion1: Different - Wavelength The laser wavelength of this device is the same as K140009 and similar to K210168. According to" IEC 60825-1:2014 Safety of laser products Part 1: Equipments 700m-1050mm laser is the emission limit of the same group, so the slight wavelength difference between 808nm will not make a difference in laser safety. In addition, the therapeutic effect of laser treatment is caused by the themal effect generated after the skin surface and is absorbed by hair follides However, according to the laser absorpion curve of human to any from 800mm to 850m belongs to the low value of water absorpion and the peak value of pigment absorption. The subtle wavelendth difference between 808mm and 810mm will not have any difference in the penetration depth of laser and the absorption effect of tissues, and will not affect the clinical effectiveness. #### Discussion2: Different - Spot Size {8}------------------------------------------------ posed device is similar to the predicate device. The output laser energy density is an important factor affecting safety. Therefore, this difference will not affect safety and effectiveness of the proposed device. Discussion 3: Different - Fluence Laser energy density is low and safety is better. #### Discussion 4: Different - Pulse Duration The pulse width of this instrument is smaller than that of K210168 and K140009, and the single pulse energy is lower, so the safety is better. ### Discussion 5: Different - Frequency The pulse frequency of this instrument is the same as K210168, higher than K140009. The product of laser repetition frequency and pulse instrument is not more than 100W. For example, when the frequency is 10HZ, the corresponding energy density is 10Jom², which is single pulse energy value of K14009 of 120 J/cm². Therefore, the safety and effectiveness will not be affected. ### Discussion 6: Different -Tissue Cooling Good skin cooling can greatly reduce the probability and serenergy. This device is same as model K14009, the sapphire on the handle tip is cooled by TEC. It's with smaller size, lighter weight, fast cooling result will improve the treatment safety. ### Discussion 7: Different - Power Supply The power supply of the device may be different from the predical safety and EMC test has been conducted on the proposed device and the test result show that the device can work normally under this difference will not affect safety and effectiveness of the proposed device. Discussion 8-14: The differences from Discussion 8-14 don't affect the safety and performance to medical device.