The IPL Hair Removal is a personal, light-based, hair reduction device intended to be sold over-thecounter directly to the end user. The device provides hair reduction using IPL technology. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device mainly contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only.

The IPL Hair Removal includes SL-B080, SL-B126, and SL-B136 three models. The difference of all models is mainly the exception of appearance and number of buttons which do not affect the intended use. For model SL-B080, it consists of an IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver, sunglasses and replacement lampshade in addition to the IPL beauty device main body and adapter. The user can control the device effectively by the buttons on the main unit. There are 2 operation buttons: Power button (turning on/off the device and selecting the level of gears) and Mode/Flash button.

For model SL-B126 and SL-B136, consisting of IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver and sunglasses in addition to the IPL beauty device main body and adapter.

The user can control the device effectively by the buttons on the main unit. There are 3 operation buttons: Power button (turning on/off the device), Auto/Manual button and Flash button.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an IPL Hair Removal device (models SL-B080, SL-B126, SL-B136). The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing new acceptance criteria through a clinical study. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as typically found in clinical performance studies, is largely not present in this regulatory document.

However, based on the provided text, I can extract and infer some information related to safety and performance testing that serves as a form of acceptance criteria for regulatory clearance.

1. Table of Acceptance Criteria (Based on Compliance with Standards) and Reported Device Performance

Acceptance Criteria (Based on Compliance with Standards)	Reported Device Performance
Biocompatibility: Device components in body contact must meet ISO 10993 standards.	Complied with: - ISO 10993-5:2009/(R)2014 (Tests for In Vitro Cytotoxicity) - ISO 10993-10:2010/(R)2014 (Tests for Irritation and Skin Sensitization)
Electrical Safety: Device must meet general and collateral safety standards for medical electrical equipment.	Complied with: - IEC 60601-1-2 (Electromagnetic compatibility) - IEC 60601-1 (Basic safety and essential performance) - IEC 60601-1-11 (Medical Electrical Systems Used in the Home Healthcare Environment) - IEC 60601-2-57 (Non-laser source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)
Eye Safety: Device must meet photobiological safety standards.	Complied with: - IEC 62471 (Photobiological safety of lamps and lamp systems) - IEC 60601-2-57 (re-emphasized for non-laser source equipment)
Usability: Device must meet standards for usability in medical electrical equipment.	Complied with: - IEC 60601-1-6 (Usability)
Software Verification and Validation: Software must meet specified requirements and mitigate hazards.	Software documentation consistent with moderate level of concern was submitted. System validation testing demonstrated all software requirement specifications are met and hazards mitigated.
Performance Equivalence: Device performance characteristics (wavelength, pulse duration, energy density, spot size) should be comparable to predicate devices.	Wavelength Range: 510-1100nm (Same as Predicate 1, Predicate 2 not publicly available)Pulse duration: 9-12 milliseconds (Similar to Predicates 1 & 2)Energy density: 2.2-4.0J/cm² (Similar to Predicates 1 & 2, noted as not raising new safety/effectiveness issues)Spot size: 3.0cm² (Same/similar to Predicates 1 & 2)

2. Sample size used for the test set and the data provenance

The document does not detail specific human subject test sets or their sample sizes for proving the device's efficacy in hair removal. The "Test Summary" primarily refers to lab bench testing for biocompatibility, electrical safety, eye safety, and software verification/validation, which do not typically involve human subjects or data provenance in the clinical sense. These tests are performed in a laboratory setting on the device itself or on materials representative of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests described are laboratory-based compliance tests against international standards, not clinical studies requiring expert-established ground truth for specific clinical outcomes.

4. Adjudication method for the test set

Not applicable. The tests described are laboratory-based compliance tests, not clinical studies that would typically involve adjudication of results by multiple human readers.

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

Not applicable. This device is an IPL hair removal device, not an AI-powered diagnostic tool, and the submission does not involve an MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm, and the submission does not describe standalone algorithm performance.

7. The type of ground truth used

The "ground truth" in this context is the international and recognized consensus standards (e.g., ISO, IEC) for safety and performance. The device is deemed safe and effective if it successfully passes these predefined tests.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set. The tests performed are for device safety and performance, not for training a model.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device and submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

July 7, 2022

Shenzhen Semlamp Intelligent Technology Co., Ltd % Cassie Lee Manger Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510530 China

Re: K221246

Trade/Device Name: IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) 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: April 20, 2022 Received: May 2, 2022

Dear Cassie Lee:

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.

{1}------------------------------------------------

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 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-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 Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K221246

Device Name

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)

Indications for Use (Describe)

The IPL Hair Removal is an over the-counter device intended for removal of unwanted body and/or facial 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary for K221246

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 878.4810.

1. Submitter's Information

Company Name: Shenzhen Semlamp Intelligent Technology Co., Ltd Address: Room 915, Lankun Building, Minkang Road 213, Zhangkeng Community, Minzhi Avenue, Longhua District, Shenzhen, Guangdong, China Contact Person (including title): Qi Wenjun (CEO) Tel: +86 13428733261 Fax: +86 0755-23490305 E-mail: 2320792967@qq.com

Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com

2. Date of the summary prepared: July 6, 2022

3. Subject Device Information

Classification Name: Light Based Over-The-Counter Hair Removal Trade Name: IPL Hair Removal Model Name: SL-B080, SL-B126, SL-B136 Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 21 CFR 878.4810 Regulatory Class: II

4. Predicate Device Information

Predicate Device 1 (Primary Predicate Device) Sponsor: Shenzhen Bosidin Technology Co., Ltd. Trade Name: IPL Home Use Hair Removal Device, model: D-1128, D-1103, D-1119, D-1129, D-1130

{4}------------------------------------------------

Classification Name: Light Based Over-The-Counter Hair Removal 510(K) Number: K192432 Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 21 CFR 878.4810 Regulation Class: 2

Predicate Device 2 (Secondary Predicate Device)

Sponsor: Shenzhen Mismon Technology Co., Ltd. Trade Name: Home Use IPL Beauty Device Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7 Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology 510(K) Number: K210311 Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 21 CFR 878.4810 Regulation Class: 2

5. Device Description

{5}------------------------------------------------

The user can control the device effectively by the buttons on the main unit. There are 3 operation buttons: Power button (turning on/off the device), Auto/Manual button and Flash button.

6. Intended Use / Indications for Use

The IPL Hair Removal is an over the-counter device intended for removal of unwanted body and/or facial hair.

7. Test Summary

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) has been evaluated the safety and performance by lab bench testing as following:

1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the IPL Home Use Hair Removal Device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:

ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity

ISO 10993-10:2010/(R)2014, Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization

2) Electrical Safety and Eye Safety

Electrical safety and Eye safety testing was performed to, and passed, the following standards:

IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility

IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance

IEC 60601-1-11 Medical Electrical Equipment –Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment

IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

{6}------------------------------------------------

IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

3) Eye Safety

IEC 62471 Photobiological safety of lamps and lamp systems

4) Software Verification and Validation

Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

8. Comparison to predicate device and conclusion

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.

		Predicate Device 1	Predicate Device 2
Elements ofComparison	Subject Device	(Primary PredicateDevice)	(Secondary PredicateDevice)	Remark
Company	Shenzhen SemlampIntelligent TechnologyCo., Ltd	Shenzhen BosidinTechnology Co.,Ltd.	Shenzhen MismonTechnology Co., Ltd.	--
Trade Name	IPL Hair Removal, Model:SL-B080, SL-B126, SL-B136	IPL Home Use HairRemoval Device	Home Use IPL BeautyDevice, model: MS-208B, MS-212B, MS-216B, MS-218B,MELSYA-M6,MELSYA-M7	--
ClassificationName	Laser surgical instrumentfor use in general andplastic surgery and indermatology	Laser surgical instrumentfor use in general andplastic surgery and indermatology	Laser surgicalinstrument for use ingeneral and plasticsurgery and indermatology	--
510(k) Number	K221246	K192432	K210311	--
Product Code	OHT	OHT	OHT	Same
Intended Use /	The IPL Hair Removal is	IPL Home Use Hair	The Home Use IPL	Same
Elements ofComparison	Subject Device	Predicate Device 1(Primary PredicateDevice)	Predicate Device 2(Secondary PredicateDevice)	Remark
Indications forUse	an over the-counterdevice intended forremoval of unwantedbody and/or facial hair.	Removal Device is anover the-counter deviceintended for removal ofunwanted body and/orfacial hair.	Beauty Device is anover the-counter deviceintended for removal ofunwanted hair such asbut not limited to smallareas such asunderarm and facialhair below the chin lineand large areas suchas legs.
Energy medium	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Same
WavelengthRange	510-1100nm	Regular window: 510nm-1100nmFilter window: 600-1100nm	Not publicly available	Same
Pulse duration	9-12 milliseconds	7.5~14ms	9-12 milliseconds	Same
Energy density	2.2-4.0J/cm²	2.0~~4.0J/cm² (applicablefor model D-1128,D1119, D-1129, D1130)2.5~~4.5J/cm² (applicablefor model D-1103)	2.6~5.1J/cm²	SimilarNote
Spot size (sizeof treatmentwindow)	3.0cm²	Regular window: 4.5cm²,2.0cm², 3.0cm²Filter window: 2.5cm²	MS208B/MS212B/MELSYAM6: 3.6cm² MS-216B/MS218B/MELSYA-M7: 3.0cm²	Same
Delivery device	Direct illumination totissue	Direct illumination totissue	Direct illumination totissue	Same
Pulsing control	Finger switch	Finger switch	Finger switch	Same
Location for use	OTC	OTC	OTC	Same
Elements ofComparison	Subject Device	Predicate Device 1(Primary PredicateDevice)	Predicate Device 2(Secondary PredicateDevice)	Remark
Safety andEMC	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 62471IEC 60601-1-6	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 62471	IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-11IEC 60601-2-57IEC 62471	Same
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

{7}------------------------------------------------

{8}------------------------------------------------

Note:

Although the "Energy density" is a similar from the predicate devices, but the value of the predicate device can override the value of the subject device, also they all complied with the IEC 60601-1-2, IEC 60601-2-57 and IEC 62471 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issue.

Final Conclusion:

The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device K192432 and K210311.

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.