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-1 PRO, IPL-1, IPL-12, and IPL-17 four models in this application. Their work principle, function, intended use, structure, and composition are the same, with differences being product appearance, size are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.

AI/ML Overview

The provided FDA 510(k) summary does not contain information on the acceptance criteria and study proving device performance as typically understood for AI/ML-driven medical devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and standard safety and performance testing.

Here's a breakdown of why the requested information is absent and what is provided:

No AI/ML Performance Study Details:
The document does not describe an AI/ML component, nor does it detail a study proving specific performance metrics (like accuracy, sensitivity, specificity) against a clinical ground truth, which would typically involve acceptance criteria, test sets, expert adjudication, or MRMC studies.

The device, "Intense Pulse Light Therapeutic Apparatus," is a physical device for hair removal and does not appear to incorporate AI or machine learning. The section titled "Software Verification and Validation" primarily addresses the software aspect within the context of electrical safety and general device functionality, classifying it as "moderate level of concern" software, which is typical for embedded control systems in medical devices, not necessarily AI.

What the Document Does Provide Regarding Performance and Equivalence:

Acceptance Criteria (Implicit via Substantial Equivalence):
- The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices (K230097 and K220669). This means the device must have the same intended use, fundamental technological characteristics, and be as safe and effective as the predicate device(s).
- Specific parameters compared (and found to be similar or within acceptable ranges) are listed in the tables. These implicitly act as performance criteria for demonstrating substantial equivalence. For example, energy density (Max 4.92 J/cm² for the subject vs. Max 5.0 J/cm² for predicate K230097), wavelength range, spot size, and output energy levels are compared.
Study Proving Device Meets Criteria (Safety and Performance Testing):
The document outlines the following standard safety and performance tests performed to demonstrate safety and effectiveness, supporting the claim of substantial equivalence:
- Biocompatibility Safety:
  - Tests performed: ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Skin Sensitization), ISO 10993-23 (Irritation).
  - Result: Passed.
- Electrical Safety and EMC:
  - Tests performed: IEC 60601-1-2 (EMC), IEC 60601-1 (Basic Safety and Essential Performance), IEC 60601-1-11 (Home Healthcare Environment), IEC 60601-2-83 (Home Light Therapy Equipment).
  - Result: Passed.
- Eye Safety:
  - Test performed: IEC 62471 (Photobiological safety of lamps and lamp systems).
  - Result: Not explicitly stated as "passed" but grouped with other passed tests under "Performance Data."
- Software Verification and Validation:
  - Description: "Software documentation consistent with moderate level of concern was submitted... System validation testing... demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." This suggests internal V&V activities rather than a clinical performance study.

Addressing the Specific Questions (where information is available or can be inferred):

A table of acceptance criteria and the reported device performance:

Acceptance Criterion (Implicit for SE)	Reported Device Performance (Subject Device)	Predicate Device K230097
Intended Use	Removal of unwanted body hair (OTC)	Same
Mode of Action	IPL	Same
Applicable Skin Type	Fitzpatrick Skin Type I-V	Same
Wavelength range	510~1200nm	470~1200nm
Energy density	Max 4.92 J/cm²	Max 5.0J/cm²
Spot size	3.3 +/- 0.25 cm²	3.0 cm² +/- 0.5 cm²
Output energy	Level 1: 6.0J to Level 5: 12.5J (±20%)	Range in 5~12.5J (±20%)
Output energy level	1 to 5 level	5 level
Pulse duration	5.84~9.24ms	4~10ms
Biocompatibility	Met ISO 10993-5, -10, -23	Not explicitly detailed but implied similar for SE
Electrical Safety/EMC	Met IEC 60601-1-2, -1, -11, -2-83	Not explicitly detailed but implied similar for SE
Eye Safety	Met IEC 62471	Not explicitly detailed but implied similar for SE

Sample size used for the test set and the data provenance: Not applicable. This refers to a clinical or AI/ML performance test set, which is not detailed here. The tests mentioned are laboratory safety and performance tests for the physical device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth or expert review is described.
Adjudication method for the test set: Not applicable.
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: Not applicable. The device is not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Safety and performance tests against recognized standards are used, not clinical ground truth in the AI/ML sense.
The sample size for the training set: Not applicable. There is no mention of an AI/ML training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter and summary for a physical Intense Pulse Light device, not an AI/ML medical device. Therefore, the detailed AI/ML performance study criteria requested are not present in this submission. The "performance data" section refers to standard electrical, biocompatibility, and eye safety testing necessary for the physical device's regulatory clearance.

Summary

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December 4, 2023

Shenzhen Greatro Electronic Technology Co., Ltd. % Bing Huang Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Center, No. 3101-90 Qianhai Road, Nanshan District Shenzhen, Guangdong 518000 China

Re: K232932

Trade/Device Name: Intense Pulse Light Therapeutic Apparatus 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: September 19, 2023 Received: September 20, 2023

Dear Bing Huang:

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/ofdocs/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 (OS) 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.

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 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).

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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-devices/deviceadvice-comprehensive-regulatory-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.

Tanisha L. Hithe -Tanisha L. و 2023.12.04 Hithe -S 20:58:14 -05'00'

Tanisha Hithe 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) K232932

Device Name

Intense Pulse Light Therapeutic Apparatus, Model(s): IPL-1 PRO, IPL-1, IPL-12, IPL-17

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 K232932

''510(k) Summary'' as required by 21 CFR Part 807.92.

Date: 2023-11-24

I. Submitter

Shenzhen Greatro Electronic Technology Co., Ltd East Side, 4/F Building A1, Xu'xing'da Industrial Park, Shiyan Sub-district, Bao'an District , Shenzhen, China Post code: 518108 Tel.: +86 755 86321189

Xinhua Yue Project Manager Tel.: + 86 139 2374 2027 Email: janis@jrdmic.com

II. Device

Name of Device: Intense Pulse Light Therapeutic Apparatus Model(s): IPL-1 PRO, IPL-1, IPL-12, IPL-17 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

Primary Predicate device: 510(k) number: K230097 Manufacturer: Shenzhen BSX Technology Electronics Co., Ltd. Trade name: IPL Hair Removal Device, BSXT101 Product code: OHT Approval date: April 6, 2023

Reference device: 510(k) number: K220669 Manufacturer: Shenzhen Junbobeauty Technology Co., Ltd. Trade name: IPL HAIR REMOVAL HANDSET, MODEL: IPL-666 Product code: OHT Approval date: May 16, 2022

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IV. Device Description

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-1 PRO, IPL-1, IPL-12, and IPL-17 four models in this application. Their work principle, function, intended use, structure, and composition are the same, with differences being product appearance, size are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.

V. Indications for Use

Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.

VI. Comparison of Technological Characteristics With the Predicate Device

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.

ComparisonElements	Subject Device	Predicate deviceK230097	Reference deviceK220669
K Number	Pending	K230097	K220669
Trade name	Intense Pulse LightTherapeutic Apparatus	IPL Hair RemovalDevice, BSXT101	IPL HAIR REMOVALHANDSET , Model:IPL-666
Regulation number	21CFR 878.4810	21CFR 878.4810	21CFR 878.4810
Device class	II	II	II
Product code	OHT	OHT	OHT
Applicable skin	Fitzpatrick Skin Type I-V	Fitzpatrick Skin Type I-V	Fitzpatrick Skin Type I-V
Wavelength range	510~1200nm	470~1200nm	470~1000nm
Energy medium	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp
Energy density	Max 4.92 J/cm²	Max 5.0J/cm²	1.3~2.49 J/cm²

The subject device is compared with the following Predicate Device in terms of intended use, design, specifications, and performance:

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ComparisonElements	Subject Device	Predicate deviceK230097	Reference deviceK220669
Spot size	$3.3+/-0.25 cm^2$	$3.0cm^2+/-0.5 cm^2$	$3 cm^2$
Output energy	Level 1: 6.0JLevel 2: 7.5JLevel 3: 9.5JLevel 4: 11.0JLevel 5: 12.5JError is ±20%	Range in 5~12.5J (±20%)	Range in 3.9J~7.47 (±20%)
Output energy level	1 to 5 level	5 level	5 level
Pulse duration	5.84~9.24ms	4~10ms	11.5~15ms
Pulsing control	Finger switch	Finger switch	Finger switch
Delivery device	Direct illumination to tissue	Direct illumination to tissue	Direct illumination to tissue
Indication for use/Intended use	The Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.	The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.	The IPL HAIR REMOVAL DEVICE is an over-the-counter device intended for removal of unwanted body and/ or facial hair.
Location for use	OTC	OTC	OTC
Treatment time	Once a week for 12 weeks	Once a week for 12 weeks	Use one time every two weeks for up to six times;Use one time every four weeks when using6-10 times.
Sterilization	Not required	No required	No required
Power supply	Input: AC100~240V 50/60zOutput: DC12V 3A	100-240v, 50/60Hz	100~240V AC Input12V 3A DC output

VII.Performance Data

The following performance data were provided in support of the substantial equivalence determination.

1) Biocompatibility Safety

The materials of the patient-directly contacting components of the subject device was performed the biocompatibility evaluation 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 Sep. 4, 2020", as recognized by FDA. The battery of testing was performed to, and passed, including:

ISO 10993-5 Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Skin Sensitization

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ISO 10993-23 Biological Evaluation of Medical Devices –Part 23: Tests for Irritation 2) Electrical Safety and EMC
Electrical safety and EMC 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 60601-2-83 Medical Electrical Equipment Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment

3) Eve 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, the subject 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 subject device Intense Pulse Light Therapeutic Apparatus is to be concluded substantial equivalent to its predicate device.

Regulation Number and Section

§ 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.