Red Wave Hair Removal

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September 24, 2021 Shenzhen Accompany Technology Co., Ltd. % Jett Lee Official Correspondent Guangdong Jianda Medical Technology Co Ltd 906 Room, Longxiang Garden, Tianhe District Guangzhou, Guangdong China Re: K212099 Trade/Device Name: Red Wave Hair Removal 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: ONF Dated: June 28, 2021 Received: July 6, 2021 Dear Jett Lee: 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. Purva Pandya 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) K212099 Device Name Red Wave Hair Removal, Model:ARH001 #### Indications for Use (Describe) The Red Wave Hair Removal Device is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, 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 device is used for adults. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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}------------------------------------------------ #### Date of the summary prepared: September 22, 2021 # 510(k) Summary 510(k) number: K212099 This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. #### 1. Submitter's Information #### Sponsor - � Company Name: Shenzhen Accompany Technology Co., Ltd. - Address: Unit. 375, Xiangnan Ruifeng Gradan, No. 22,Guimiao Road, Xuefu Community, � Nanshan Street, Nanshan District, Shenzhen, Guangdong, China. - Phone: 86-075522674547 � - � Contact Person (including title): Ms. Yourong Lai (Regulation engineer) - � E-mail: laiyourong@accompany.tech #### Application Correspondent: - Company: Guangdong Jianda Medical Technology Co Ltd � - Address: 906 Room, Longxiang Garden, Tianhe district, Guangzhou, China � - Contact name: Jett Lee � - Email: jianda-lee@foxmail.com � - Phone: 13512755282 � #### 2. Subject Device Information - Trade Name: Red Wave Hair Removal, Model: ARH001 � - Light Based Prescription-Use Hair Removal � Common Name: - Powered Light Based Non-Laser Surgical Instrument With Classification name: � Thermal Effect - � Review Panel: General & Plastic Surgery - ONF � Product Code: - � Regulation Class: 2 - Regulation Number: 878.4810 � {4}------------------------------------------------ ## 3. Predicate Device Information | Sponsor | CyDen Limited. | Conair Corporation | Kam Yuen Plastic<br>Products Ltd. | |----------------------|--------------------------------------------------------|-------------------------------|-----------------------------------| | Device Name | Ipulse<br>Gold Hair<br>Device<br>Smoothskin<br>Removal | Lumilisse IPL Hair<br>Remover | Aimanfun<br>Comfort<br>Lumea | | 510(k) Number | K160968 | K172791 | K190820 | | Product Code | OHT | OHT | ONF | | Regulation<br>Number | 878.4810 | 878.4810 | 878.4810 | | Regulation Class | 2 | 2 | 2 | ## 4. Device Description Red Wave Hair Removal, Model: ARH001, is a small prescription-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. It is a personal Light-Based Hair Removal System. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 285g, and the size is 152.9x101.5x94.8mm (H*W*D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. ## 5. Intended Use / Indications for Use The Red Wave Hair Removal Device is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-tem, 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 device is used for adults. ## 6. Design The device works in exactly the same way as professional IPL devices used by salons and clinics. A flash of Intense Pulsed Light (IPL) is directed at the skin and the light energy travels along the pigment in the hair, where it is converted to heat energy. It is the heat energy that disables the hair follicle preventing the hair from re-growing. Treated hairs will shed naturally within a couple of weeks of treatment and will not regrow. Each treatment will only be effective on hairs that are in their active growth phase at the time, so it is important to follow a course of treatments over a twelve-week period to ensure all hairs are treated. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the Red Wave Hair Removal Device is not properly applied to the treatment area (in full contact {5}------------------------------------------------ with the skin), the device cannot be triggered a pulse emitting. Body lamp cartidge can be used for body hair below the neck. It can cover an area of 2.7 cm², and it is specially designed for large areas on underarms, bikini line, ams and legs. It can remove hair in a large scope rapidly. Do not use Body lamp cartridge on the areas around eyes or near eyelid. The product can flash for 50,000 times, and when the flash time comes to 50000 times, all five lamps of energy level indicators will flash when power on the device and it would not be operable. ## 7. Materials There is one part of patient- directly contracting components in the subject device as the following list. | Component of<br>Device Requiring<br>Biocompatibility | Material of<br>Component | Body Contact<br>Category<br>(ISO 10993-1) | Contact Duration<br>(ISO 10993-1) | |------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------| | IPL Lamp output<br>window | ABS: PC2805 | Surface-contacting<br>device: skin | Maximum 30<br>minutes (< 24hours) | We provide ISO 10993-5, -10 test reports for the following biocompatibility evaluation. - Cytotoxicity - Sensitization - Irritation or intracutaneous reactivity ## 8. Physical characteristics | Basic Unit Characteristics | | |----------------------------------------------|----------------------------------------------------------------| | Compliance* with 21 CFR 898 | N/A | | Main Unit Weight | 285 g | | Main Unit Dimension | 152.9*101.5*94.8 mm(H*W*D) | | Housing Materials of main unit | ABS+PC | | Indicator | Indicates power information, intensity level<br>information. | | Environment for operation | Temperature: 5°C~35°C<br>Relative humidity: 20%~65% | | Storage and Transport Conditions | Temperature: 0°C~40°C<br>Humidity: 10~90% | | Compliance with Voluntary<br>Standards | Yes, Comply with IEC 60601-1, IEC 60601-1-2,<br>IEC 60601-2-57 | | Patient leakage current | Comply with IEC 60601-1 | | Power Source | Supplied by external adapter | | Software/Firmware/Microprocessor<br>Control? | Yes | | Specification | | | Output Intensity Level | 5 | | Output energy | 5.4-13.5J | {6}------------------------------------------------ | Emitted Light Spectrum | 620nm~1200nm Max | |------------------------|----------------------| | Max Energy density | Up to 5.0 J/cm² | | Treatment Area | 2.7 [cm²] | | Max number of Flashes: | 50000 times | | Power Supply | 100-240 VAC, 50/60Hz | | Technology | IPL | ## 10. Comparison to predicate device and conclusion The technological characteristics, features, specifications, materials, and intended use of Red Wave Hair Removal, Model: ARH001 is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. | Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Predicate Device III | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name<br>and Model | Red Wave Hair<br>Removal, Model:<br>ARH001 | iPulse SmoothSkin<br>Gold | Lumilisse IPL Hair<br>Remover | Aimanfun Lumea<br>Comfort (Model: A-<br>2788) | | 510(k) Number | K212099 | K160968 | K172791 | K190820 | | Manufacturer | Shenzhen<br>Accompany<br>Technology Co.,<br>Ltd. | CyDen Ltd | Conair Corporation | Kam Yuen Plastic<br>Products Ltd. | | Intended Use | The Red Wave<br>Hair Removal<br>Device is<br>indicated for<br>patient removal of<br>unwanted hair by<br>using a selective<br>photothermal<br>treatment under<br>the direction of a<br>physician, after<br>training by a<br>healthcare<br>professional. The<br>device is also<br>indicated for the<br>permanent<br>reduction in hair<br>regrowth, defined<br>as the long-term, | The iPulse<br>SmoothSkin Gold<br>Hair<br>Removal System is<br>indicated for the<br>removal of<br>unwanted hair. The<br>iPulse<br>SmoothSkin Gold<br>is also indicated for<br>the permanent<br>reduction in hair<br>regrowth, defined<br>as the long-term,<br>stable reduction in<br>the number of<br>hairs regrowing<br>when measured at<br>6,<br>9 and 12 months | The Lumilisse IPL<br>(Intense Pulsed<br>Light) Hair<br>Remover is an<br>over-the-counter<br>device intended for<br>the removal of<br>unwanted hair. | The Aimanfun<br>Lumea Comfort<br>(Model: A-2788) is<br>indicated for<br>patient removal of<br>unwanted hair by<br>using a selective<br>photothermal<br>treatment under<br>the direction of a<br>physician, after<br>training by a<br>healthcare<br>professional. The<br>Aimanfun Lumea<br>Comfort is also<br>intended for | | Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Predicate Device III | | | stable reduction in<br>the number of hairs<br>re-growing when<br>measured at 6, 9<br>and 12 months<br>after the<br>completion of a<br>treatment regime.<br>The device is used<br>for adults. | after the<br>completion of a<br>treatment regime. | | permanent<br>reduction in<br>unwanted hair.<br>Permanent hair<br>reduction is defined<br>as the long-term<br>stable reduction in<br>the number of hairs<br>regrowing when<br>measured at 6. 9.<br>and 12 months<br>after the<br>completion of a<br>treatment regimen. | | Source Energy | Supplied by<br>external adapter | Supplied by<br>external adapter | Supplied by<br>external adapter | Supplied by<br>external adapter | | 'Use'<br>Classification | Prescription use | OTC | OTC | Prescription use | | Device<br>Classification | Class II | Class II | Class II | Class II | | Device Type | Intense Pulsed<br>Light | Intense Pulsed<br>Light | Intense Pulsed<br>Light | Intense Pulsed<br>Light | | Wavelength<br>(nm) | 620nm~1200nm | 510nm~1100nm | 550-1200 nm<br>(when using with<br>body lens)<br>600-1200 nm<br>(when using with<br>facial lens) | 475~1200nm | | Max. Fluence<br>(J/cm²) | Max 5.0<br>[Joules/cm²] | Max 6 [Joules/cm²] | 4.5[Joules/cm²] | Max 4.5<br>[Joules/cm²] | | Spot Size (cm²) | 2.7 cm² | 3 cm² | -- | 3.0 cm² | | Light Intensity | 2.0 -5 J/cm² | 3-6J/cm2 | Level 1: 2.0 J/cm²<br>Level 2: 3.0 J/cm²<br>Level 3: 3.5 J/cm²<br>Level 4: 4.0 J/cm²<br>Level 5: 4.5 J/cm² | -- | | Pulse duration | 10.0ms ± 1.0ms | 2-10 ms | -- | 3 milliseconds | | Elements of<br>Comparison | Subject Device | Predicate Device I | Predicate Device II | Predicate Device III | | Energy medium | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | | Pulsing Control | Finger switch | Finger switch | Finger switch | Finger switch | | Number of<br>Output Channels | One channel | One channel | One channel | One channel | | Output Intensity<br>Level | 5 levels | 5 levels | 5 levels | 5 levels | | Software/Firmwa<br>re/Microprocess<br>or Control? | Yes | Yes | Yes | Yes | | 60601 Compliance<br>with Voluntary<br>Standards | Yes<br>Comply with IEC<br>60601-1 and IEC<br>60601-1-2,<br>IEC60601-2-57 | Yes<br>Comply with IEC<br>60601-1 and IEC<br>60601-1-2,<br>IEC60601-2-57 | Yes<br>Comply with IEC<br>60601-1 and IEC<br>60601-1-2,<br>IEC60601-2-57 | Yes<br>Comply with IEC<br>60601-1 and IEC<br>60601-1-2,<br>IEC60601-2-57 | | Compliance*<br>with 21 CFR 898 | No | No | No | No | | Weight | 285g | -- | -- | 200g | | Dimensions | 152.9*101.5*94.8<br>mm(H*W*D) | -- | -- | 138.9*82*47.3mm(<br>H*W*D) | | Standards | | | | | | Biocompatibility | All user directly<br>contacting<br>materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting<br>materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting<br>materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting<br>materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | | Electrical Safety | Comply with<br>IEC60601-1 and<br>IEC60601-2-57 | Comply with<br>IEC 60601-1 and<br>IEC 60601-2-57 | Comply with<br>IEC 60601-1 and<br>IEC 60601-2-57 | Comply with<br>IEC 60601-1 and<br>IEC 60601-2-57 | {7}------------------------------------------------ {8}------------------------------------------------ ## 11. Test Summary Red Wave Hair Removal, Model: ARH001 has been evaluated the safety and performance by lab bench testing as following: - Electrical safety test according to IEC 60601-1: 2005+COR1:2006+COR2:2007+AMD1:2012 and IEC 60601-2-57: 2011 standards {9}------------------------------------------------ - Electromagnetic compatibility test according to IEC 60601-1-2: 2014 standard � - � Software verification and validation test according to the requirements of the FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices" 2005" ## 12. Conclusion: The subject device "Red Wave Hair Removal, Model: ARH001" is substantially equivalent to all predicate devices.