(69 days)
No
The description focuses on basic sensor technology (skin sensor) and standard electrical/software safety testing, with no mention of AI/ML terms or capabilities.
Yes
The product is explicitly named "Intense Pulse Light Therapeutic Apparatus" in the "Intended Use / Indications for Use" and "Device Description" sections, indicating its therapeutic nature.
No
The device is an Intense Pulse Light Therapeutic Apparatus intended for removal of unwanted body hair, which is a therapeutic rather than diagnostic function. It works to reduce hair growth, not to diagnose a condition.
No
The device description clearly outlines hardware components such as a Xenon lamp, built-in skin sensor, external power adapter, and finger switch. It also mentions electrical safety and biocompatibility testing, which are associated with hardware devices. While software verification and validation are mentioned, this is for the software controlling the hardware, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "removal of unwanted body hair." This is a therapeutic or cosmetic 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 or injury.
- Device Description: The description focuses on the mechanism of action (IPL technology for hair reduction) and safety features related to skin contact and light emission. It does not mention any analysis of biological samples.
- Lack of IVD-related information: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Intense Pulse Light Therapeutic Apparatus is a therapeutic/cosmetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body
Indicated Patient Age Range
Not Found
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)
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:
- 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 devices -Part 23: Tests for skin irritation
- Electrical Safety and EMC: Electrical safety and EMC testing was performed and passed, the following standards:
- IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
- 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.
- 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
- IEC 60601-2-83 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- 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, the subject 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.
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
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.
1
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
2
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
3
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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4
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 |
|---|---|
| Manufacturer | |
| information | Submitter's Name: Shenzhen Greatro Electronic Technology |
| Co., Ltd | |
| Address: | |
| East Side, 4/F Building A1, Xu'xing'da Industrial Park, Shiyan | |
| Sub-district, Bao'an District, Shenzhen, China. 518108 | |
| Contact person: Xinhua Yue | |
| TEL: +86 139 2374 2027 | |
| E-Mail: janis@jrdmic.com | |
| Submission | |
| Correspondent | Contact person: Ms Lucy.Yan |
| E-Mail: lucy.yan@aivikon.com | |
| Company: Shenzhen Greatro Electronic Technology Co., Ltd | |
| Address: | |
| East Side, 4/F Building A1, Xu'xing'da Industrial Park, Shiyan | |
| Sub-district, Bao'an District, Shenzhen, China. 518108 | |
| Tel: +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 Surgery |
| Classification name: Laser surgical instrument for use in | |
| general and plastic surgery and in dermatology | |
| Regulation Number: 21 CFR 878.4810 | |
| Device Class: II | |
| Product Code: OHT | |
| 510(k) type of submission | Traditional |
3 Primary predicate Device Information and Reference predicate Device Information
5
| 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:
6
| Characteristics | Subject device | Predicate device
(K232932) | Reference Device
(K223618) | Remark |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Device Name | Intense Pulse Light
Therapeutic Apparatus | Intense Pulse Light
Therapeutic Apparatus | IPL Hair Removal
Device | NA |
| Device Model | IPL-18 BF, IPL-18 FG | IPL-1 PRO, IPL-1, IPL-12,
IPL-17 | UI06 PL, UI06 PN, UI06
JL, UI06 BR, UI06 DB,
UI06 PR, UI06 OG,
UI06 RD | NA |
| Manufacturer | Shenzhen Greatro
Electronic Technology
Co., Ltd | Shenzhen Greatro
Electronic Technology
Co., Ltd | Shenzhen Ulike Smart
Electronics Co., Ltd | NA |
| Product code | OHT | OHT | OHT | NA |
| Classification | II | II | II | NA |
| Intended Use/
Indication for
Use | Intense Pulse Light
Therapeutic Apparatus is
an over-the-counter
device intended for
removal of unwanted body
hair. | Intense Pulse Light
Therapeutic Apparatus is
an over-the-counter device
intended for removal
of unwanted body hair. | IPL Hair Removal
Device 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 at6, 9 and 12
months after the
completion of a
treatment regime. | NA |
| Prescription or
OTC | 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:133.58348mm
IPL-1: 133.58348mm
IPL-12:13483.548.5mm
IPL-17: 140.57845mm | 58x34x179 mm (W x H
x D) | Different
Note 01 |
| Weight | IPL-18 BF: 213g
IPL-18 FG: 201g | IPL-1 PRO:200g
IPL-1: 194g
IPL-12: 183g
IPL-17: 184g | / | |
| Power source | Supplied by external
adapter | Supplied by external
adapter | Supplied by external
adapter | Same |
| Power supply | Input:
AC100240V50/60Hz240V50/60Hz
Output: DC12V 3A | Input:
AC100
Output: 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
7
| Shenzhen Greatro Electronic Technology Co., Ltd |
|---|
| 510(k)s_510(k) Summary K242595 |
| Wavelength
| range | 510~1200nm | 510~1200nm | 560-1200mm | Same |
|---|---|---|---|---|
| Energy density | IPL-18 BF: | |||
| 1.28~4.80J/cm²; | ||||
| IPL-18 FG: | ||||
| 1.52~5.89J/cm² | Max. 4.92 J/cm² | 3~6 J/cm² | ||
| Output energy | Level 1: 6.0±1.2J | |||
| Level 2: 7.5±1.5J | ||||
| Level 3: 9.5±1.9J | ||||
| Level 4: 11.0±2.2J | ||||
| Level 5: 13.0±2.6J | ||||
| Error is ±20% | Level 1: 6.0J | |||
| Level 2: 7.5J | ||||
| Level 3: 9.5J | ||||
| Level 4: 11.0J | ||||
| Level 5: 12.5J | ||||
| Error is ±20% | 9.9~19.8J | Different | ||
| Note 02 | ||||
| Output energy | ||||
| level | 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 | Different | |
| Note 02 | ||||
| Pulse duration | 10.0±3.0ms | 5.84~9.24ms | 1ms~7ms | Different |
| Note 03 | ||||
| Pulsing control | Finger switch | Finger switch | Finger switch | Same |
| Delivery device | Direct illumination to | |||
| tissue | Direct illumination to tissue | Direct illumination to | ||
| tissue | Same | |||
| Availability of | ||||
| skin sensors | ||||
| (that used to | ||||
| identify the | ||||
| presence or | ||||
| absence of skin | ||||
| areas) | Presence | Presence | Presence | Same |
| Software/Firmw | ||||
| are/Microproce | ||||
| ss or Control? | Yes | Yes | Yes | Same |
| Skin-contacting | ||||
| components | Device enclosure and | |||
| treatment panel | Device enclosure and light | |||
| outlet panel | Enclosure and | |||
| treatment window | Different | |||
| Note 04 | ||||
| Materials of | ||||
| skin-contacting | ||||
| components | IPL-18 BF: PC+ABS | |||
| plastic, POM, Glass, and | ||||
| Aluminum alloy; | ||||
| IPL-18 FG: PC+ABS | ||||
| plastic, POM, Glass | PC+ABS plastic, Glass | ABS, PC, Crystal | ||
| application | Different | |||
| Note 04 | ||||
| Materials | ||||
| statement | All user directly contacting | |||
| materials are compliance | ||||
| with ISO10993-5, | ||||
| ISO10993-10 and ISO | ||||
| 10993-23 requirements. | All user directly contacting | |||
| materials are compliance | ||||
| with ISO10993-5 and | ||||
| ISO10993-10 | ||||
| requirements. | All user directly | |||
| contacting materials are | ||||
| compliance with | ||||
| ISO10993-5 and | ||||
| ISO10993-10 | ||||
| requirements. | SE | |||
| EMC safety | ||||
| statement | Comply with IEC60601-1- | |||
| 2 requirements | Comply with IEC60601-1- | |||
| 2 requirements | Comply with IEC60601- | |||
| 1-2 requirements | Same | |||
| Electrical | ||||
| safety | ||||
| statement | Comply with IEC60601-1, | |||
| IEC60601-1-11, | ||||
| IEC60601-2-83 | ||||
| requirements | Comply with IEC60601-1, | |||
| IEC60601-1-11, | ||||
| IEC60601-2-83 | ||||
| requirements | Comply with IEC60601- | |||
| 1, IEC60601-1-11, IEC | ||||
| 60601-2-83 | ||||
| requirements | Same | |||
| Photobiological | Comply with IEC62471 | Comply with IEC62471 | Comply with IEC62471 | Same |
| statement | requirements. | requirements. | requirements. | |
| Environment | ||||
| for operation | Temperature: | |||
| 5°C~30°CHumidity: | ||||
| ≤80%RH | Temperature: | |||
| 5°C~30°CHumidity: | ||||
| ≤80%RH | / | SE | ||
| Environment | ||||
| for storage | Temperature: - | |||
| 10°C~60°CHumidity: | ||||
| 5%~90% | Temperature: - | |||
| 10°C~60°CHumidity: | ||||
| 5%~90% | / | SE |
8
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
9
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).