(89 days)
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. The software validation mentioned is standard for medical devices and does not indicate AI/ML.
No.
The device's intended use is for cosmetic hair removal and permanent hair reduction by heating hair roots, not for treating a disease, injury, or other medical condition.
No
The device is intended for hair removal and hair reduction, not for diagnosing medical conditions.
No
The device description explicitly states it is a physical device that uses Intense Pulsed Light (IPL) technology and includes hardware components like a treatment window head, facial adaptor, battery charger/AC cord, and operates on AC power. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal and permanent reduction of unwanted body and facial hair. This is a physical treatment applied to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device uses Intense Pulsed Light (IPL) to heat hair roots. This is a therapeutic mechanism, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, measure a substance in a biological sample, or provide information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It is also intended for permanent reduction in unwanted 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.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
IPL Salon Hair Reduction System, Model: F60001, a small over-the-counter device, is a homeuse device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). Emission activation 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 650g, and the size is 143 x69.5 x 43mm (HWD).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
Anatomical Site
legs, underarms, bikini line, chest, stomach, back, arms and on the face below the cheekbones
Indicated Patient Age Range
adults
Intended User / Care Setting
Homeuse device / 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)
No clinical testing was performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
September 11, 2018 Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt % Iris Fung PM SGS-CSTC Standards Technical Services Co., Ltd. 108 Kezhu Road Scientech Park Guangzhou Economic & Technology Dept Guangzhou. CN
Re: K181568
Trade/Device Name: IPL Salon Hair Reduction System 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: June 10, 2018 Received: June 14, 2018
Dear 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/ofdocs/ofpmn.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.
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
1
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 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 R. Stevenson -S3
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)
Device Name
IPL Salon Hair Reduction System
Indications for Use (Describe)
The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It is also intended for permanent reduction in unwanted 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.
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 8, 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
Applicant
- � Company Name: Medical Device Branch of Zhangzhou Easepal Industrial Co.,Ltd.
- Address: 4th Floor of Building #1, No.228, Jiaosong Road, Taiwanese Investment Zone, � Zhangzhou, Fujian, China.
- Phone: +86 1366 609 7743 �
- � Fax:+86 059 6626 8816
- � Contact Person (including title): Bruce Wu
- E-mail: brucewu@easepal.com.cn �
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 Salon Hair Reduction System
- IPL Salon Hair Reduction System Common Name: �
- Light Based Over-The-Counter Hair Removal Classification name: �
- General & Plastic Surgery Review Panel: �
- ОНТ � Product Code:
- Regulation Class: 2 �
- 878.4810 Regulation Number: �
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3. Predicate Device Information
| Predicate Type | Primary Predicate Device | Reference Predicate Device |
|---|---|---|
| 510(k) Number | K161428 | K140631 |
| Regulation Number | 878.4810 | 878.4810 |
| Product Code | OHT | ONF |
| Device Name | PerfectSmooth | Lumena FH Hair Removal System |
| Sponsor | Shen Zhen CosBeauty Co., Ltd. | Shaser, Inc. |
2. Device Description
IPL Salon Hair Reduction System, Model: F60001, a small over-the-counter device, is a homeuse device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). Emission activation 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 650g, and the size is 143 x69.5 x 43mm (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 IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It is also intended for permanent reduction in unwanted hair. 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.
6. Design
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 regrowing. 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 IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered. The device is designed for use on the legs, underarms, bikini line, chest, stomach, back, arms and on the face below the cheekbones [although not recommended for use on male facial hair].
7. Materials
Listed below is the material that comes in contact with the user.
| Component of | Material of | Body Contact | Contact Duration |
|---|---|---|---|
| -------------- | ------------- | -------------- | ------------------ |
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| Device Requiring
Biocompatibility | Component | Category
(ISO 10993-1) | (ISO 10993-1) |
|--------------------------------------|-----------|------------------------------------|----------------------------------|
| IPL Lamp output
window | ABS | Surface-contacting
device: skin | Maximum 30
minutes(