(88 days)
Not Found
No
The summary describes a standard IPL hair removal device with no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is intended for hair removal, which is typically considered a cosmetic procedure and not a therapeutic medical treatment for a disease or medical condition.
No
The device is described as a light-based hair removal device for reducing unwanted hair, not for diagnosing medical conditions.
No
The device description explicitly states it consists of an "IPL main body and adapter two parts, and a detachable lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp." This indicates the device includes significant hardware components beyond just 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 "removal of unwanted hair." This is a cosmetic or aesthetic purpose, not a diagnostic one. IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: The device description focuses on the mechanism of action (IPL technology) for hair reduction. It doesn't mention any analysis of biological samples.
- Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens.
- Detection or measurement of analytes (substances in the body).
- Providing diagnostic information.
- Mention of laboratory settings or clinical diagnostic procedures.
The device is clearly described as a personal, over-the-counter device for hair removal, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
The Light based hair removal device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. The device consists of IPL main body and adapter two parts, and a detachable lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from adapter via an external power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
underarm and facial hair below the chin line and large areas such as legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home healthcare environment (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)
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of the Light based hair removal device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:
- ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10:2010/(R)2014, Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization
- Electrical Safety and Eye Safety: Electrical safety and Eye safety testing was performed to, and passed, the following standards:
- IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- Eye Safety:
- IEC 62471 Photobiological safety of lamps and lamp systems
- Software Verification and Validation: Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Summary: Based on the above performance as documented in this application, Light based hair removal device was found to have a safety and effectiveness profile that is similar to the predicate device.
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.
Not Found
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.
0
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.
May 11, 2018
Shenzhen GSD Tech Co., Ltd % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road, S Shenzhen, 518000 Cn
Re: K180383
Trade/Device Name: Light based hair removal device 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: January 31, 2018 Received: February 12, 2018
Dear Rain Yip:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-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 -53
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
2
Indications for Use
510(k) Number (if known) K180383
Device Name Light based hair removal device
Indications for Use (Describe)
Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.
| 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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3
510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2018-01-31
I. Submitter
SHENZHEN GSD TECH CO., LTD BUILDING A JUNSD HI-TECH PARK, WEST OF BAO'AN RD., WATCH & CLOCK BASE, GUANGMING DISTRICT, SHENZHEN, GUANGDONG, CHINA Tel.: +86 755 2916 9431 ext.8040 Tax: +86 755 2910 9786
Ziyi Gui Regulatory Engineer Tel: +86 130 7784 1845 Email: gzy@gsd.com.cn
II. Device
Name of Device: Light based hair removal device Common or Usual Name: Light Based Over-The-Counter Hair Removal Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810
III. Predicate Device
The predicate devices are listed as below:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shen Zhen CosBeauty | |||
| Co., Ltd | Perfectsmooth | K161428 | March 23, 2017 |
| CyDen Limited | iPulse SmoothSkin Gold Hair | ||
| Removal System | K160968 | April 04, 2016 |
IV. Device Description
The Light based hair removal device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL
4
technology. The device consists of IPL main body and adapter two parts, and a detachable lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from adapter via an external power.
V. Indications for Use
Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.
VI. Comparison of Technological Characteristics With the Predicate Device
The Light based hair removal device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, the Light based hair removal device may be found substantially equivalent to its predicate device.
Light based hair removal device is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- K161428, "PerfectSmooth", manufactured by "Shen Zhen CosBeauty Co., Ltd" in Guangdong, China
| Comparison
| Elements | Subject Device | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| K Number | Pending | K161428 | K160968 |
| Common name | Light Based Over-The- | ||
| Counter Hair Removal | Light Based Over-The- | ||
| Counter Hair Removal | Light Based Over-The- | ||
| Counter Hair Removal | |||
| Trade name | Light based hair | ||
| removal device | PerfectSmooth | iPulse SmoothSkin | |
| Gold Hair Removal | |||
| System | |||
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Pulse duration | 2-3 milliseconds | 11-13 milliseconds | 2-10 milliseconds |
| Energy density | 4.2 J/cm2Max. | 4.7J/cm2Max. | 3~6 J/cm2 |
| Spot size | 1.05cm×2.95cm | ||
| (3.1 cm3) | 4.5 cm2 | 3 (3cm by 1cm) | |
| Delivery device | Direct illumination to | Direct illumination | Direct illumination |
- K160968. "iPulse SmoothSkin Gold Hair Removal System ", manufactured by "CyDen Limited" in Wales, UK
5
| Comparison
| Elements | Subject Device | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| tissue | tissue | tissue | |
| Pulsing control | Finger switch | Finger switch | Finger switch |
| Indication | |||
| for | |||
| use/Intended use | Light based hair | ||
| removal device is an | |||
| over-the-counter device | |||
| intended for removal of | |||
| unwanted hair such as | |||
| but not limited to small | |||
| areas such as underarm | |||
| and facial hair below | |||
| the chin line and large | |||
| areas such as legs, | |||
| excluding patients with | |||
| Fitzpatrick Skin | |||
| Phototypes VI. | The PerfectSmooth is | ||
| an | |||
| over-the-counter | |||
| device intended for | |||
| removal of unwanted | |||
| hair such as but not | |||
| limited to small areas | |||
| such as underarm and | |||
| facial hair below the | |||
| chin line and large areas | |||
| such as legs. | The iPulse SmoothSkin | ||
| Gold Hair Removal | |||
| System is indicated for | |||
| the removal of | |||
| unwanted hair. The | |||
| iPulse Smoothskin Gold | |||
| 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. | |||
| Location for use | OTC | OTC | OTC |
VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the Light based hair removal device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:
-
ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010/(R)2014, Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization
2) Electrical Safety and Eye Safety
6
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
-
IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
3) Eye Safety
-
IEC 62471 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Summary
Based on the above performance as documented in this application, Light based hair removal device was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the Light based hair removal device is to be concluded substantial equivalent to its predicate devices.