(69 days)
Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.
The Intense Pulse Light Therapeutic Apparatus 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 Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.The Intense Pulse Light Therapeutic Apparatus is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse.There are IPL-18 BF and IPL-18 FG two models in this application. Their work principle, intended use, structure, appearance, size, and composition are the same, with differences being product function are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.
The FDA 510(k) summary for the Intense Pulse Light Therapeutic Apparatus (K242595) does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria for its intended use (removal of unwanted body hair).
Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: The device shares the same intended use as its primary predicate: "removal of unwanted body hair."
- Operational Characteristics and Design: The summary compares various physical and technical characteristics (wavelength range, energy density, pulse duration, light source, etc.) to show similarities or non-significant differences with predicate devices.
- Compliance with Recognized Standards: The substantial equivalence is supported by showing compliance with a suite of international standards related to biocompatibility, electrical safety, electromagnetic compatibility (EMC), photobiological safety, and software verification/validation.
Here's an breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria for hair removal effectiveness (e.g., X% hair reduction after Y treatments) or reported performance data against such criteria. The reported performance is implicitly deemed acceptable by virtue of:
- Substantial Equivalence to Predicate Devices: The key "acceptance criterion" here is that the subject device's characteristics and safety/effectiveness profile are comparable enough to legally marketed predicate devices.
- Compliance with Safety Standards: Meeting standards for biocompatibility, electrical safety, EMC, and photobiological safety is presented as the primary performance data.
| Domain | Acceptance Criterion (Implicit/Standard) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate: Over-the-counter device intended for removal of unwanted body hair. | The subject device states the identical intended use as the primary predicate (K232932). |
| Device Characteristics | Similar operational characteristics (light source, wavelength, energy density range, pulse duration, spot size) to predicate devices. | Differences noted (e.g., exact dimensions, specific energy density/output energy values, exact spot size, pulse duration, materials) were deemed not to raise new safety/effectiveness issues. The "Energy density" of the subject device (IPL-18 BF: 1.28 |
| Biocompatibility | Compliance with ISO 10993 series (cytotoxicity, sensitization, irritation) for body-contacting components. | Performed and passed: ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization), ISO 10993-23:2021 (skin irritation). |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-83 standards. | Performed and passed: IEC 60601-1, IEC 60601-1-11, IEC 60601-2-83. |
| EMC | Compliance with IEC 60601-1-2. | Performed and passed: IEC 60601-1-2. |
| Eye Safety | Compliance with IEC 62471 (photobiological safety). | Performed and passed: IEC 62471. |
| Software | Software verification and validation demonstrating all requirements met and hazards mitigated to acceptable risk levels (moderate level of concern). | System validation testing demonstrated all software requirement specifications are met and all software hazards mitigated. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical test set with human subjects to evaluate hair removal efficacy. The "test set" in this submission refers to the components and systems subjected to engineering (biocompatibility, electrical safety, EMC, etc.) and software validation testing. The data provenance for these engineering tests is generally from the manufacturer's testing or accredited labs, not specific countries or patient populations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as there is no clinical test set for efficacy evaluation described in the submitted 510(k) summary. The "ground truth" for the engineering tests would be the specifications and requirements of the relevant IEC and ISO standards. The experts involved would be the engineers and quality personnel conducting the tests and verifying compliance. Their specific qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no clinical test set requiring adjudication in this 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is an Intense Pulse Light Therapeutic Apparatus for hair removal, which is not an AI-powered diagnostic device requiring human reader interpretation. No MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical light therapy apparatus, not an algorithm. Performance is demonstrated through compliance with safety and engineering standards and comparison of physical and operational characteristics to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the compliance testing:
- Biocompatibility, Electrical Safety, EMC, Eye Safety: The "ground truth" is compliance with the specified international standards (ISO 10993 series, IEC 60601 series, IEC 62471). This means the device met the predefined thresholds and requirements set out in these widely accepted safety and performance standards.
- Software Verification and Validation: The "ground truth" is that the software met its specified requirements and mitigated identified hazards, as demonstrated through validation testing against defined specifications.
There is no "ground truth" for hair removal efficacy (e.g., pre/post treatment hair counts, subject satisfaction scores, expert assessment of hair reduction) presented in this 510(k) summary.
8. The sample size for the training set
This is not applicable. The device is an Intense Pulse Light Therapeutic Apparatus. It is not an AI/ML algorithm that requires a training set. The "design" and "development" of the device would involve engineering prototypes and testing, but not in the context of a "training set" as it would apply to AI.
9. How the ground truth for the training set was established
This question is not applicable as the device is not an AI/ML system requiring a training set with established ground truth.
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November 6, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Greatro Electronic Technology Co., Ltd Lucy Yan Regulatory Manager East Side, 4/F Building A1, Xu'xing'da Industrial Park Shiyan Sub-district, Bao'an District Shenzhen, Guangdong 518108 China
Re: K242595
Trade/Device Name: Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) 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: July 18, 2024 Received: August 30, 2024
Dear Lucy Yan:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Yan Fu -S
Digitally signed by Yan
Date: 2024.11.06
23:57:14-05'00'
Tanisha Hithe for Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & 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) K242595
Device Name
Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
Indications for Use (Describe)
Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.
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 K242595
This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1 Administrative Information
| Submission Date | July. 15, 2024 |
|---|---|
| Manufacturerinformation | Submitter's Name: Shenzhen Greatro Electronic TechnologyCo., LtdAddress:East Side, 4/F Building A1, Xu'xing'da Industrial Park, ShiyanSub-district, Bao'an District, Shenzhen, China. 518108Contact person: Xinhua YueTEL: +86 139 2374 2027E-Mail: janis@jrdmic.com |
| SubmissionCorrespondent | Contact person: Ms Lucy.YanE-Mail: lucy.yan@aivikon.comCompany: Shenzhen Greatro Electronic Technology Co., LtdAddress:East Side, 4/F Building A1, Xu'xing'da Industrial Park, ShiyanSub-district, Bao'an District, Shenzhen, China. 518108Tel: +8613316972203 |
2 Device Information
| Common name of the device | IPL Hair Removal Device |
|---|---|
| Trade name of the device | Intense Pulse Light Therapeutic Apparatus |
| Type/Model of the device | IPL-18 BF, IPL-18 FG |
| Classification information | Classification panel: General & Plastic SurgeryClassification name: Laser surgical instrument for use ingeneral and plastic surgery and in dermatologyRegulation Number: 21 CFR 878.4810Device Class: IIProduct Code: OHT |
| 510(k) type of submission | Traditional |
3 Primary predicate Device Information and Reference predicate Device Information
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| Predicate Device: | Intense Pulse Light Therapeutic Apparatus |
|---|---|
| Sponsor: | Shenzhen Greatro Electronic Technology Co., Ltd. |
| Device: | Intense Pulse Light Therapeutic Apparatus, Model(s):IPL-1 PRO, IPL-1, IPL-12, IPL-17 |
| 510(K) Number: | K232932 |
| Product code: | OHT |
| Approval date: | December 4, 2023 |
| Reference Device: | IPL Hair Removal Device |
| Sponsor: | Shenzhen Ulike Smart Electronics Co., Ltd |
| Device: | IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL,UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD |
| 510(K) Number: | K223618 |
| Product code: | OHT |
| Approval date: | February 28, 2023 |
4 Device Descriptions
The Intense Pulse Light Therapeutic Apparatus 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 Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does notinvolve any cutting or pulling, reducing hair growth with minimal pain.The Intense Pulse Light Therapeutic Apparatus is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to thetreated skin, the device will not emit the light pulse.There are IPL-18 BF and IPL-18 FG two models in this application. Their work principle, intended use, structure, appearance, size, and composition are the same, with differences being product function are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.
5 Intended Use/ Indications for Use
Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.
6 SE Comparisons
The subject device Intense Pulse Light Therapeutic Apparatus 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 device 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 subject device may be found substantially equivalent to its predicate device.The subject device is compared with the following Predicate Devices in terms of intended use, design, specifications, and performance:
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| Characteristics | Subject device | Predicate device(K232932) | Reference Device(K223618) | Remark |
|---|---|---|---|---|
| Device Name | Intense Pulse LightTherapeutic Apparatus | Intense Pulse LightTherapeutic Apparatus | IPL Hair RemovalDevice | NA |
| Device Model | IPL-18 BF, IPL-18 FG | IPL-1 PRO, IPL-1, IPL-12,IPL-17 | UI06 PL, UI06 PN, UI06JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06 RD | NA |
| Manufacturer | Shenzhen GreatroElectronic TechnologyCo., Ltd | Shenzhen GreatroElectronic TechnologyCo., Ltd | Shenzhen Ulike SmartElectronics Co., Ltd | NA |
| Product code | OHT | OHT | OHT | NA |
| Classification | II | II | II | NA |
| Intended Use/Indication forUse | Intense Pulse LightTherapeutic Apparatus isan over-the-counterdevice intended forremoval of unwanted bodyhair. | Intense Pulse LightTherapeutic Apparatus isan over-the-counter deviceintended for removalof unwanted body hair. | IPL Hair RemovalDevice is indicated forthe removal ofunwanted hair. Thedevice is also indicatedfor the permanentreduction in hairregrowth, defined asthe long-term, stablereduction in the numberof hairs regrowing whenmeasured at6, 9 and 12months after thecompletion of atreatment regime. | NA |
| Prescription orOTC | OTC | OTC | OTC | Same |
| Applicable skin | Fitzpatrick skin types I-V | Fitzpatrick skin types I-V | Fitzpatrick skin types I-V | Same |
| Dimension | IPL-18 BF: 1547946mm;IPL-18 FG: 1547946mm | IPL-1PRO:133.58348mmIPL-1: 133.58348mmIPL-12:13483.548.5mmIPL-17: 140.57845mm | 58x34x179 mm (W x Hx D) | DifferentNote 01 |
| Weight | IPL-18 BF: 213gIPL-18 FG: 201g | IPL-1 PRO:200gIPL-1: 194gIPL-12: 183gIPL-17: 184g | / | |
| Power source | Supplied by externaladapter | Supplied by externaladapter | Supplied by externaladapter | Same |
| Power supply | Input:AC100~240V50/60HzOutput: DC12V 3A | Input:AC100~240V50/60HzOutput: DC12V 3A | 100~240V, 50/60Hz | Same |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy medium | Xenon Arc lamp | Xenon Arc lamp | Xenon Arc lamp | Same |
Table 1. Substantial Equivalence Comparison
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| Shenzhen Greatro Electronic Technology Co., Ltd |
|---|
| 510(k)s_510(k) Summary K242595 |
| Wavelengthrange | 510~1200nm | 510~1200nm | 560-1200mm | Same |
|---|---|---|---|---|
| Energy density | IPL-18 BF:1.28 | Max. 4.92 J/cm² | 3~6 J/cm² | |
| Output energy | Level 1: 6.0±1.2JLevel 2: 7.5±1.5JLevel 3: 9.5±1.9JLevel 4: 11.0±2.2JLevel 5: 13.0±2.6JError is ±20% | Level 1: 6.0JLevel 2: 7.5JLevel 3: 9.5JLevel 4: 11.0JLevel 5: 12.5JError is ±20% | 9.9~19.8J | DifferentNote 02 |
| Output energylevel | 1 to 5 level | 1 to 5 level | 1 to 3 level | Same |
| Spot size | IPL-18 BF: (3.5±0.25)cm²;IPL-18 FG: (2.9±0.25) cm² | 3.3(±0.25) cm² | 3.3cm² | DifferentNote 02 |
| Pulse duration | 10.0±3.0ms | 5.84~9.24ms | 1ms~7ms | DifferentNote 03 |
| Pulsing control | Finger switch | Finger switch | Finger switch | Same |
| Delivery device | Direct illumination totissue | Direct illumination to tissue | Direct illumination totissue | Same |
| Availability ofskin sensors(that used toidentify thepresence orabsence of skinareas) | Presence | Presence | Presence | Same |
| Software/Firmware/Microprocess or Control? | Yes | Yes | Yes | Same |
| Skin-contactingcomponents | Device enclosure andtreatment panel | Device enclosure and lightoutlet panel | Enclosure andtreatment window | DifferentNote 04 |
| Materials ofskin-contactingcomponents | IPL-18 BF: PC+ABSplastic, POM, Glass, andAluminum alloy;IPL-18 FG: PC+ABSplastic, POM, Glass | PC+ABS plastic, Glass | ABS, PC, Crystalapplication | DifferentNote 04 |
| Materialsstatement | All user directly contactingmaterials are compliancewith ISO10993-5,ISO10993-10 and ISO10993-23 requirements. | All user directly contactingmaterials are compliancewith ISO10993-5 andISO10993-10requirements. | All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements. | SE |
| EMC safetystatement | Comply with IEC60601-1-2 requirements | Comply with IEC60601-1-2 requirements | Comply with IEC60601-1-2 requirements | Same |
| Electricalsafetystatement | Comply with IEC60601-1,IEC60601-1-11,IEC60601-2-83requirements | Comply with IEC60601-1,IEC60601-1-11,IEC60601-2-83requirements | Comply with IEC60601-1, IEC60601-1-11, IEC60601-2-83requirements | Same |
| Photobiological | Comply with IEC62471 | Comply with IEC62471 | Comply with IEC62471 | Same |
| statement | requirements. | requirements. | requirements. | |
| Environmentfor operation | Temperature:5°C~30°CHumidity:≤80%RH | Temperature:5°C~30°CHumidity:≤80%RH | / | SE |
| Environmentfor storage | Temperature: -10°C~60°CHumidity:5%~90% | Temperature: -10°C~60°CHumidity:5%~90% | / | SE |
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Shenzhen Greatro Electronic Technology Co., Ltd 510(k)s 510(k) Summary K242595
Note 01: The "Weight", "Dimension", is belonging to basic physical characteristics, although it is a little different from the predicate devices, it will not affect the main function and the intended use of the device. They all also comply with IEC60601-1 requirements. Besides, the subtle change of the physical characteristics will not affect the critical functions or normal use, and not raise any safety or effectiveness issues
Note 02: The max "Energy density" of the subject device is lower than the Reference device, so the subject device is substantially equivalent to the device. Although there is a minor difference in the spot size between the subject device and the predicate device, the spot size and output energy level which is related to energy density. The subject device complies with IEC60601-1 and IEC60601-2-83 and since the difference in energy density is not significant and be substantially equivalent, so this difference will not raise any safety or effectiveness issue.
Note03: The "Pulse duration" of the subject device is little different from the predicate device. But the subject device complies with IEC60601-1 and IEC60601-2-83; so this difference will not raise any safety or effectiveness issues.
Note04: Although the "skin-contact components" and the "Materials of skin-contacting components" of the subject device and predicate device are not exactly the same, the skincontacting components of the subject device has been tested and satisfied the standard requirements of ISO 10993-1. So this difference will not raise any safety/effectiveness problems.
These different technological characteristics of the subject devices do not raise different questions of safety and effectiveness. Thus, the subject device is Substantially Equivalent (SE) to the predicate devices which is legally marketed in US.
7 Performance Data
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 IPL 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 September 4, 2020", as recognized by FDA. The following testing was performed and passed, including:
- Biocompatibility Testing
-
ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro や cytotoxicity
-
や ISO 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin
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sensitization
- や ISO 10993-23:2021, Biological evaluation of medical devices -Part 23: Tests for skin irritation
- Electrical Safety and EMC
Electrical safety and EMC testing was performed and passed, the following standards:
- ゃ IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
- ゃ IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
- や IEC 60601-111 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
- ゃ IEC 60601-2-83 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment 3) Eve Safetv
- ゃ 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, the subject device was found to have a safety and effectiveness profile that is similar to the predicate device.
8 Conclusions
The subject device:
Intense Pulse Light Therapeutic Apparatus is respectively substantially equivalent to the predicate device (Intense Pulse Light Therapeutic Apparatus) manufactured by Shenzhen Greatro Electronic Technology Co. (K232932) and reference device (IPL Hair Removal Device) manufactured by Shenzhen Ulike Smart Electronics Co., Ltd (K223618).
§ 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.