(53 days)
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 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 lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from adapter via an external power.
The provided document is a 510(k) Summary for a Light Based Hair Removal Device GP592. It discusses the device's substantial equivalence to a predicate device but does not include information about clinical studies with human participants to demonstrate specific acceptance criteria or device performance in terms of efficacy or safety. The document primarily focuses on nonclinical tests for safety and electromagnetic compatibility.
Therefore, requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as it outlines nonclinical testing and substantial equivalence, not results from a human study demonstrating efficacy against acceptance criteria.
The document states:
- Nonclinical tests submitted:
- Safety test: IEC 60601-1: 2005+A1: 2012+A2:2020, IEC 60601-1-11: 2015
- EMC test: IEC 60601-1-2: 2020
- Reliability test: IEC 62471: 2006, IEC 60601-2-83: 2019
- Biocompatibility test: ISO 10993-5: 2009, ISO 10993-10: 2021, ISO 10993-23: 2021
- Conclusion: "None of the tests demonstrated any design characteristics that may adversely affect patient safety. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests."
This indicates that the device met the requirements of these specific technical and safety standards, which serve as the "acceptance criteria" in this context. However, these are not performance metrics like sensitivity, specificity, or outcomes from a human clinical trial.
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March 3, 2023
Shenzhen GSD Tech Co., Ltd. Huifang Yao Regulatory Engineer Building A, JUNSD Hi-Tech Park, West of Bao'An RD. Watch & Clock Base, Guangming District Shenzhen, Guangdong 518106 China
Re: K230060
Trade/Device Name: Light Based Hair Removal Device GP592 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 9, 2023 Received: January 9, 2023
Dear Huifang Yao:
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 medical devices and radiation-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.
Jianting Wang -S
Jianting Wang Acting 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) K230060
Device Name Light Based Hair Removal Device GP592
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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510(k) Summary
Date Prepared: 2023-01-09
This 510(k) Summary is being submitted in accordance with requirements of Title 21 CFR Section 807.92.
1. Submitter information
Shenzhen GSD Tech Co., Ltd Add .: Building A, JUNSD Hi-Tech Park, West of Bao'An RD. Watch & Clock Base, Guangming District, Shenzhen, China 518106 Establishment Registration Number: 3006580954
Contact Person: Huifang Yao Position: Regulatory Engineer Phone: +86 15018526594 E-mail: zoe.yao190322@qq.com.com
2. Device information
Device name: Light Based Hair Removal Device GP592 Trade name: Light Based Hair Removal Device Model number: GP592 Regulation number: 21CFR 878.4810 Regulation name: Light Based Over-The-Counter Hair Removal Regulatory class: II Panel: General & Plastic Surgery Product code: OHT
3. Predicate device information
510(k) Number: K180383 Device Name: Light Based Hair Removal Device Manufacturer: Shenzhen GSD Tech Co., Ltd.
4. 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 lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from adapter via an external power.
5. Intended use
The 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
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and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.
| Description | Subject device | Predicate device | Remark |
|---|---|---|---|
| 510 (k) number | Pending | K180383 | / |
| Common name | Light Based Over-The-Counter HairRemoval | Light Based Over-The-Counter HairRemoval | Same |
| Trade name/modelNo. | Light Based Hair Removal DeviceModel: GP592 | Light Based Hair Removal DeviceModel: GP586 | / |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Pulse duration | 1~3milliseconds | 2~3milliseconds | Similar |
| Energy density | $4.93J/cm^2$ Max. | $4.2J/cm^2$ Max. | SimilarNote 1 |
| Spot size | 1.05cm*2.95cm (3.1cm²) | 1.05cm*2.95cm (3.1cm²) | Same |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue | Same |
| Pulsing control | Finger switch | Finger switch | Same |
| Indication foruse/Intended use | Light based hair removal device is anover-the-counter device intended forremoval of unwanted hair such as butnot limited to small areas such asunderarm and facial hair below thechin line and large areas such as legs,excluding patients with FitzpatrickSkin Phototypes VI. | Light based hair removal device is anover-the-counter device intended forremoval of unwanted hair such as butnot limited to small areas such asunderarm and facial hair below thechin line and large areas such as legs,excluding patients with FitzpatrickSkin Phototypes VI. | Same |
| Location for use | OTC | OTC | Same |
6. Technological characteristics and substantial equivalence:
Note 1: Though the pulse duration and energy density are little different from the predicate device, they comply with the requirements of safety and performance related standards, and the differences are not likely to raise different questions of safety or effectiveness issue or adversely affect patient safety.
7. Nonclinical tests submitted
- . Safety test
IEC 60601-1: 2005+A1: 2012+A2:2020
Medical electrical equipment - Part1: General requirements for basic safety and essential performance
IEC 60601-1-11: 2015
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare
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environment
● EMC test
IEC 60601-1-2: 2020
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances-Requirements and tests
● Reliability test IEC 62471: 2006 Photobiological safety of lamps and lamp systems IEC 60601-2-83: 2019 Medical electrical equipment - Part 2-83: General requirements for basic safety and essential performance of home light therapy equipment
● Biocompatibility test ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10: 2021 Biological evaluation of medical devices – Part 10: Tests for skin sensitization ISO 10993-23: 2021 Biological evaluation of medical device — Part 23: Tests for skin irritation
None of the tests demonstrated any design characteristics that may adversely affect patient safety. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests.
8. Conclusion
The subject devices have the same intended use and same technological characteristics as the predicate device. Moreover the differences between the subject and predicate don't raise different questions of safety or effectiveness. Thus, the subject device is substantially equivalent to the Predicate Device.
§ 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.