(266 days)
Not Found
No
The summary describes a standard IPL hair removal device with no mention of AI or ML capabilities in its operation, intended use, or performance studies.
No
The device is indicated for permanent reduction in hair regrowth, which is a cosmetic purpose rather than treating a disease or health condition.
No
Explanation: The device is an IPL hair removal device indicated for the removal and permanent reduction of unwanted hair. Its purpose is to treat hair growth, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is a physical device utilizing Intense Pulsed Light (IPL) technology and includes hardware components like a treatment window head, facial adaptor, and battery charger/AC cord.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The IPL Hair Removal Device Joy Version uses Intense Pulsed Light (IPL) to target hair follicles and reduce hair growth. It works externally on the skin and does not involve analyzing samples taken from the body.
- Intended Use: The intended use is for the removal and permanent reduction of unwanted hair, which is a cosmetic or aesthetic purpose, not a diagnostic one.
Therefore, this device falls under the category of a therapeutic or aesthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IPL Hair Removal Device Joy Version is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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. The device is used for adults with Fitzpatrick skin types I - IV.
Product codes
OHT
Device Description
IPL Hair Removal Device Model: CB-027, a small over-the-counter, is a home-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. A personal Light-Based Hair Removal System. Emission is by finger switch. Device includes a treatment window head, a facial adaptor and battery charger/AC cord.It is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 402g, and the size is 126 x 78 x 200mm (H x W x D).The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light (IPL)
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Over-The-Counter Use
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)
Usability study:
Usability testing (OTC Study) was completed in 78 subjects to evaluate device human factors and label comprehension.
These usability study tests demonstrate that the device and its labeling can meet with the requirement:
- the lay user can self-select themselves as being appropriate users of this device by the external box labeling, 2) the lay user can apply the treatment safely and correctly according to the instructions for use, and 3) the lay user can understand all indications, contraindications, warnings and precautions, and be able to identify whether they are within any contraindicated group; and be able to understand the user manual.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 and 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 7, 2018
Shen Zhen CosBeauty Co., Ltd Ms. Iris Fung Regulation manager SGS-CSTC Standards Technical Services Co., Ltd. 198 KEZHU Road, SCIENTECH Park Guangzhou Guangzhou. Cn
Re: K173813
Trade/Device Name: IPL Hair Removal Device Joy Version 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: OHT Dated: August 28, 2018 Received: August 31, 2018
Dear Ms. Iris Fung:
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/cfpmr/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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, Jennifer Stevensor
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K173813
Device Name
IPL Hair Removal Device Joy Version, Model: CB-027
Indications for Use (Describe)
The IPL Hair Removal Device Joy Version is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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. The device is used for adults with Fitzpatrick skin types I - IV.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Date of the summary prepared: September 7, 2018
510(k) Summary
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 CosBeauty Technology Co., Ltd.
- Address: UnitA-3F, Qiao De Industrial Park, Tian Liao, Guang Ming District, Shenzhen, � China
- Phone: +86 1831 685 8036 �
- � Fax: +86 755 8629 0505
- � Contact Person (including title): Nicole Hu
- E-mail: lizan@cos-beauty.com �
Application Correspondent:
- � SGS-CSTC Standards Technical Services Co., Ltd.
- Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology �
Development
District, Guangzhou, Guangdong, CHINA
- � Contact Person: Ms. Iris Fung
- Tel: +86-20-32136908 �
- Email: Iris.Fung@sgs.com �
2. Subject Device Information
- � Trade Name: IPL Hair Removal Device Joy Version, Model: CB-027
- Light Based Over-The-Counter Hair Removal � Common Name:
- Laser surgical instrument for use in general and plastic � Classification name: surgery and in dermatology
- General & Plastic Surgery � Review Panel:
- ОНТ Product Code: �
- 2 � Regulation Class:
- 878.4810 � Regulation Number:
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3. Predicate Device Information
| Sponsor | Cyden Limited | Shenzhen CosBeauty
Technology Co., Ltd. |
|----------------------|-----------------------------------------------------|--------------------------------------------|
| Device Name | Ipulse
Smoothskin Gold
Hair Removal
Device | PerfectSmooth |
| 510(k) Number | K160968 | K161428 |
| Product Code | ONF | OHT |
| Regulation
Number | 878.4810 | 878.4810 |
| Regulation Class | 2 | 2 |
2. Device Description
IPL Hair Removal Device Model: CB-027, a small over-the-counter, is a home-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. A personal Light-Based Hair Removal System. Emission is by finger switch. Device includes a treatment window head, a facial adaptor and battery charger/AC cord.It is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 402g, and the size is 126 x 78 x 200mm (H x W x 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 IPL Hair Removal Device Joy Version is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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. The device is used for adults with Fitzpatrick skin types I – IV.
6. Design
The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggerred a pulse emitting. Body lamp cartridge can be used for body hair below the neck. It can cover an area of 4.2cm2, and it is specially designed for large areas on legs, arms, back and abdomen. It can remove hair in a large scope rapidly. Do not use Body lamp cartridge on face. A filter has been installed in the face lamp cartridge. It can cover an area of 2cm2, and it can be used to remove hair on upper lip, chin and sideburns. Do not use this lamp cartridge on the areas around eyes or near eyelid. The product can flash for 300,000 times, and it shall not be used when the flash counter is displaying "000000".
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7. Materials
There are two 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) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| Housing | ABS | Surface-contacting
device: skin | Maximum 30
minutes(