(80 days)
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.
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 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 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 (HWD). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Based on the provided text, the document is specifically a 510(k) summary for the Red Wave Hair Removal device. It mostly focuses on demonstrating substantial equivalence to predicate devices rather than detailing a direct acceptance criteria study for its performance in hair removal. Therefore, much of the requested information regarding specific acceptance criteria, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, and detailed ground truth establishment for a performance study is not present. The document mainly describes safety and electrical performance testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria for hair removal efficacy/performance. Instead, it describes a substantial equivalence comparison to predicate devices, implying that its performance is comparable.
The "Test Summary" section (on page 9) does list safety and electrical tests. For these, the acceptance criteria are generally "compliance" with the mentioned IEC standards.
| Acceptance Criteria (for Safety/Electrical) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1: 2005+COR1:2006+COR2:2007+AMD1:2012 (Electrical safety) | The device "has been evaluated the safety and performance by lab bench testing" and implicitly "complies" as per the Conclusion section indicating substantial equivalence without new safety/effectiveness issues. |
| Compliance with IEC 60601-2-57: 2011 (Specific requirements for light sources for aesthetic and therapeutic use) | Implicitly "complies" as above. |
| Compliance with IEC 60601-1-2: 2014 (Electromagnetic compatibility) | Implicitly "complies" as above. |
| Compliance with FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices" (Software verification and validation) | Implicitly "complies" as above, stating "Software verification and validation test according to the requirements of the FDA guidance." |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Test reports for ISO 10993-5 and -10 provided, indicating compliance. |
2. Sample size used for the test set and the data provenance
For the safety and electrical tests, the sample size is not specified but typically involves a small number of devices (e.g., a few units) for bench testing. The data provenance is "lab bench testing" conducted by or for Shenzhen Accompany Technology Co., Ltd. (the manufacturer). This is a prospective test for the device, not retrospective human data.
For hair removal performance, no specific test set or sample size for a clinical study is described within this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided because no clinical study for device performance is detailed in this 510(k) summary. The document does mention the device is to be used "under the direction of a physician, after training by a healthcare professional."
4. Adjudication method for the test set
Not applicable, as no clinical study for device performance with expert adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an IPL hair removal device, not an AI-powered diagnostic system that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone hardware device that performs physical light-based treatment. There is no AI algorithm component described for standalone performance evaluation in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety and electrical tests, the "ground truth" is adherence to the specified international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57) and FDA guidance for software. For biocompatibility, it's compliance with ISO 10993-5 and -10.
For hair removal performance, the document relies on 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." However, it does not explicitly state that a clinical trial was conducted for this device to establish this outcome as part of the 510(k) submission, instead implying equivalence to predicates which likely supported this claim with clinical data.
8. The sample size for the training set
Not applicable, as this is a hardware device submission, not an AI/ML software submission with a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a hardware device submission, not an AI/ML software submission with a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
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.
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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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 �
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3. Predicate Device Information
| Sponsor | CyDen Limited. | Conair Corporation | Kam Yuen PlasticProducts Ltd. |
|---|---|---|---|
| Device Name | IpulseGold HairDeviceSmoothskinRemoval | Lumilisse IPL HairRemover | AimanfunComfortLumea |
| 510(k) Number | K160968 | K172791 | K190820 |
| Product Code | OHT | OHT | ONF |
| RegulationNumber | 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 (HWD). 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
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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 ofDevice RequiringBiocompatibility | Material ofComponent | Body ContactCategory(ISO 10993-1) | Contact Duration(ISO 10993-1) |
|---|---|---|---|
| IPL Lamp outputwindow | ABS: PC2805 | Surface-contactingdevice: skin | Maximum 30minutes (< 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 | 152.9101.594.8 mm(HWD) |
| Housing Materials of main unit | ABS+PC |
| Indicator | Indicates power information, intensity levelinformation. |
| Environment for operation | Temperature: 5°C~35°CRelative humidity: 20%~65% |
| Storage and Transport Conditions | Temperature: 0°C |
| Compliance with VoluntaryStandards | Yes, Comply with IEC 60601-1, IEC 60601-1-2,IEC 60601-2-57 |
| Patient leakage current | Comply with IEC 60601-1 |
| Power Source | Supplied by external adapter |
| Software/Firmware/MicroprocessorControl? | Yes |
| Specification | |
| Output Intensity Level | 5 |
| Output energy | 5.4-13.5J |
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| 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 ofComparison | Subject Device | Predicate Device I | Predicate Device II | Predicate Device III |
|---|---|---|---|---|
| Device Nameand Model | Red Wave HairRemoval, Model:ARH001 | iPulse SmoothSkinGold | Lumilisse IPL HairRemover | Aimanfun LumeaComfort (Model: A-2788) |
| 510(k) Number | K212099 | K160968 | K172791 | K190820 |
| Manufacturer | ShenzhenAccompanyTechnology Co.,Ltd. | CyDen Ltd | Conair Corporation | Kam Yuen PlasticProducts Ltd. |
| Intended Use | The Red WaveHair RemovalDevice isindicated forpatient removal ofunwanted hair byusing a selectivephotothermaltreatment underthe direction of aphysician, aftertraining by ahealthcareprofessional. Thedevice is alsoindicated for thepermanentreduction in hairregrowth, definedas the long-term, | The iPulseSmoothSkin GoldHairRemoval System isindicated for theremoval ofunwanted hair. TheiPulseSmoothSkin Goldis also indicated forthe permanentreduction in hairregrowth, definedas the long-term,stable reduction inthe number ofhairs regrowingwhen measured at6,9 and 12 months | The Lumilisse IPL(Intense PulsedLight) HairRemover is anover-the-counterdevice intended forthe removal ofunwanted hair. | The AimanfunLumea Comfort(Model: A-2788) isindicated forpatient removal ofunwanted hair byusing a selectivephotothermaltreatment underthe direction of aphysician, aftertraining by ahealthcareprofessional. TheAimanfun LumeaComfort is alsointended for |
| Elements ofComparison | Subject Device | Predicate Device I | Predicate Device II | Predicate Device III |
| stable reduction inthe number of hairsre-growing whenmeasured at 6, 9and 12 monthsafter thecompletion of atreatment regime.The device is usedfor adults. | after thecompletion of atreatment regime. | permanentreduction inunwanted hair.Permanent hairreduction is definedas the long-termstable reduction inthe number of hairsregrowing whenmeasured at 6. 9.and 12 monthsafter thecompletion of atreatment regimen. | ||
| Source Energy | Supplied byexternal adapter | Supplied byexternal adapter | Supplied byexternal adapter | Supplied byexternal adapter |
| 'Use'Classification | Prescription use | OTC | OTC | Prescription use |
| DeviceClassification | Class II | Class II | Class II | Class II |
| Device Type | Intense PulsedLight | Intense PulsedLight | Intense PulsedLight | Intense PulsedLight |
| Wavelength(nm) | 620nm~1200nm | 510nm~1100nm | 550-1200 nm(when using withbody lens)600-1200 nm(when using withfacial lens) | 475~1200nm |
| Max. Fluence(J/cm²) | Max 5.0[Joules/cm²] | Max 6 [Joules/cm²] | 4.5[Joules/cm²] | Max 4.5[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/cm²Level 2: 3.0 J/cm²Level 3: 3.5 J/cm²Level 4: 4.0 J/cm²Level 5: 4.5 J/cm² | -- |
| Pulse duration | 10.0ms ± 1.0ms | 2-10 ms | -- | 3 milliseconds |
| Elements ofComparison | Subject Device | Predicate Device I | Predicate Device II | Predicate Device III |
| Energy medium | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Xenon ArcFlashlamp |
| Pulsing Control | Finger switch | Finger switch | Finger switch | Finger switch |
| Number ofOutput Channels | One channel | One channel | One channel | One channel |
| Output IntensityLevel | 5 levels | 5 levels | 5 levels | 5 levels |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Yes |
| 60601 Compliancewith VoluntaryStandards | YesComply with IEC60601-1 and IEC60601-1-2,IEC60601-2-57 | YesComply with IEC60601-1 and IEC60601-1-2,IEC60601-2-57 | YesComply with IEC60601-1 and IEC60601-1-2,IEC60601-2-57 | YesComply with IEC60601-1 and IEC60601-1-2,IEC60601-2-57 |
| Compliance*with 21 CFR 898 | No | No | No | No |
| Weight | 285g | -- | -- | 200g |
| Dimensions | 152.9101.594.8mm(HWD) | -- | -- | 138.98247.3mm(HWD) |
| Standards | ||||
| Biocompatibility | All user directlycontactingmaterials arecompliance withISO10993-5 andISO10993-10requirements. | All user directlycontactingmaterials arecompliance withISO10993-5 andISO10993-10requirements. | All user directlycontactingmaterials arecompliance withISO10993-5 andISO10993-10requirements. | All user directlycontactingmaterials arecompliance withISO10993-5 andISO10993-10requirements. |
| Electrical Safety | Comply withIEC60601-1 andIEC60601-2-57 | Comply withIEC 60601-1 andIEC 60601-2-57 | Comply withIEC 60601-1 andIEC 60601-2-57 | Comply withIEC 60601-1 andIEC 60601-2-57 |
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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
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- 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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.