(80 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The technology described is standard Intense Pulsed Light (IPL).
Yes
The device is used for the "permanent reduction in hair regrowth", which is a treatment for a condition (unwanted hair) and provides a therapeutic effect (hair reduction).
No
The device is described as a hair removal device that uses Intense Pulsed Light (IPL) for permanent hair reduction. Its purpose is treatment, not diagnosis.
No
The device description explicitly states it is a "small prescription-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL)" and includes physical components like an "IPL DEVICE, Power supply". It also mentions electrical safety and electromagnetic compatibility testing, which are relevant to hardware. While software verification and validation are mentioned, the core function and components are hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Red Wave Hair Removal Device Function: The description clearly states that the Red Wave Hair Removal Device uses Intense Pulsed Light (IPL) to treat hair follicles on the body's surface for hair removal and reduction. It does not involve analyzing any specimens taken from the body.
The device is a therapeutic device that applies energy to the body for a physical effect, not a diagnostic device that analyzes biological samples.
N/A
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-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.
Product codes
ONF
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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light (IPL)
Anatomical Site
Body hair below the neck (underarms, bikini line, arms, and legs).
Indicated Patient Age Range
adults
Intended User / Care Setting
Physician, after training by a healthcare professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and performance were evaluated by lab bench testing:
- Electrical safety test according to IEC 60601-1: 2005+COR1:2006+COR2:2007+AMD1:2012 and IEC 60601-2-57: 2011 standards
- 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"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
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
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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 Plastic
Products Ltd. |
|----------------------|--------------------------------------------------------|-------------------------------|-----------------------------------|
| Device Name | Ipulse
Gold Hair
Device
Smoothskin
Removal | Lumilisse IPL Hair
Remover | Aimanfun
Comfort
Lumea |
| 510(k) Number | K160968 | K172791 | K190820 |
| Product Code | OHT | OHT | ONF |
| Regulation
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 (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
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
Device Requiring
Biocompatibility | Material of
Component | Body Contact
Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| IPL Lamp output
window | ABS: PC2805 | Surface-contacting
device: skin | Maximum 30
minutes (