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 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. For model SL-B287 and SL-B329, they consist of IPL beauty device main body and power adapter (12V3A) 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 sunglass. 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, select light intensity level), Flash button (to start flashing) and loe Cooling button (to select ice cooling mode and switch manual / auto flash mode). For model SL-B301-1 and SL-B328, consisting of an IPL beauty device main body and power adapter (12V2A) 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, sunglass and replacement lampshade. 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.

AI/ML Overview

The provided text is a 510(k) summary for an IPL Hair Removal device. It mostly focuses on comparing the subject device to predicate devices for substantial equivalence and outlining non-clinical tests conducted. Unfortunately, it explicitly states that "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, I cannot provide information on acceptance criteria based on clinical studies, device performance from such studies, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, or training set details as this information is not present in the given document.

The document only details non-clinical tests for electrical safety, electromagnetic compatibility, biocompatibility, and software verification/validation.

Here's the information that can be extracted based on the provided text regarding non-clinical tests:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Standard Compliance)	Reported Device Performance
IEC 60601-1 (Medical electrical equipment: General requirements for basic safety and essential performance)	Complied
IEC 60601-1-11 (Medical Electrical Equipment: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment)	Complied
IEC 60601-2-57 (Medical Electrical Equipment: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)	Complied
IEC 60601-1-2 (Medical electrical equipment: Electromagnetic disturbances - Requirements and tests)	Complied
IEC 62471 (Photobiological safety of lamps and lamp systems)	Complied
ISO 10993-5 (Biocompatibility: Cytotoxicity)	Complied
ISO 10993-10 (Biocompatibility: Sensitization and Skin Irritation)	Complied
Software Verification and Validation (FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices")	Conducted and documentation provided
Usability Testing (IEC 62366-1 and IEC 60601-1-6)	Conducted

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

Not applicable for clinical studies. The document mentions non-clinical tests, for which "test sets" in the context of clinical data/patients are not relevant. Details about the specific samples (e.g., number of units tested) for electrical, EMC, and biocompatibility tests are not provided.
Data Provenance: Not applicable as no clinical data is presented.

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

Not applicable. No clinical data or expert evaluations for ground truth establishment are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical data or adjudication for a test set is mentioned.

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. The device is an IPL Hair Removal device, not an AI-assisted diagnostic or interpretative tool. No MRMC study was conducted.

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

Not applicable. The device is a physical IPL hair removal device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" is typically defined by the standards themselves, and compliance is assessed against the requirements of those standards.

8. The sample size for the training set:

Not applicable. No clinical data or machine learning model requiring a training set is mentioned for the device. The software mentioned is for device control, not for data analysis or interpretation with AI.

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

Not applicable. No training set for an AI/ML model is mentioned.

Summary

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

Re: K240969

Trade/Device Name: IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328) 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: March 27, 2024 Received: April 9, 2024

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 (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.

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"

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(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 OS 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 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.

for

Yan Fu -

e: 2024.05.31 09:10:04 -04'00'

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) K240969

Device Name

IPL Hair Removal (SL-B287, SL-B329, SLB301-1, SL-B328)

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)

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510(k) Summary of K240969

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

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 Post code: 518131 E-mail: info@semlamp.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

Subject Device Information: 2.

Classification Name: Light Based Over-The-Counter Hair Removal Trade Name: IPL Hair Removal Model Name: SL-B287, SL-B329, SL-B301-1, SL-B328 Review Panel: General & Plastic Surgery Product Code: OHT Requlation Number: 21 CFR 878.4810 Requlatory Class: II

Predicate Device Information 3.

Primary Predicate Device

Sponsor: Shenzhen Lescolton Electrical Appliance Co., Ltd. Trade Name: IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) Classification Name: Light Based Over-The-Counter Hair Removal 510(K) Number: K232499 Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 21 CFR 878.4810 Requlation Class: II

Reference Device

Sponsor: Shenzhen Wochuan Electronic Co., Ltd Trade Name: IPL Hair Removal, Model: W-1095, W-1098 Classification Name: Light Based Over-The-Counter Hair Removal 510(K) Number: K232124 Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 21 CFR 878.4810 Regulation Class: II

4. Device Description

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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, select light intensity level), Flash button (to start flashing) and loe Cooling button (to select ice cooling mode and switch manual / auto flash mode).

For model SL-B301-1 and SL-B328, consisting of an IPL beauty device main body and power adapter (12V2A) 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, sunglass and replacement lampshade.

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.

Intended Use / Indications for Use 5.

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

Elements ofComparison	Subject Device	Primary PredicateDevice	Reference Device	Remark
Company	Shenzhen SemlampIntelligent TechnologyCo., Ltd	Shenzhen LescoltonElectrical ApplianceCo., Ltd.	Shenzhen WochuanElectronic Co., Ltd	--
Trade Name	IPL Hair Removal, Model:SL-B287, SL-B329, SL-B301-1, SL-B328	IPL Hair RemovalDevice (LS-T106,LS-T107, LS-T108)	IPL Hair Removal,Model W-1095, W-1098	--
ClassificationName	Light Based Over-The-Counter Hair Removal	Light Based Over-The-Counter HairRemoval	Light Based Over-The-Counter HairRemoval	--
510(k) Number	K240969	K232499	K232124	--
Product Code	OHT	OHT	OHT	Same
Class	II	II	II	Sames
Intended Use /Indications forUse	The IPL Hair Removal isan over the-counterdevice intended forremoval of unwantedbody and/or facial hair.	The IPL HairRemoval Device isan over-the-counterdevice intended forremoval of unwantedbody and/ or facialhair	IPL Hair Removal isan over-the-counterdevice intended forremoval of unwantedbody and/or facialhair.	Same
Prescription orOTC	OTC	OTC	OTC	Same
Light source	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	Same
Energy medium	Xenon Arc Flashlamp	Xenon Arc	Xenon Arc Flashlamp	Same

Comparison to predicate devices 6.

Compare with the predicate devices, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between the subject

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		Flashlamp
WavelengthRange	470nm-1200nm	LS-T106: 610-1200nm LS-T107:560-1200nm LS-T108: 470-1200nm	470nm-1100nm	Same
Pulse duration	9-12 milliseconds	LS-T106: 0.64-2.4msLS-T107: 7.2-10.8msLS-T108: 6.8-10.2ms	4-13ms	SimilarNote 1
Energy density	SL-B287: 2.2-5.3J/cm²SL-B329: 2.2-5.3J/cm²SL-B301-1: 1.9-3.4J/cm²SL-B328: 1.9-3.4J/cm²	LS-T106: 2.0-4.87J/cm² LS-T107:2.16-5.18J/cm² LS-T108: 2.0-5.62J/cm²	W-1095:1.67~~4.46J/cm²W-1098:1.16~~2.79J/cm²	SimilarNote 1
Spot size (size oftreatment window)	SL-B287: 3.6 cm²SL-B329: 3.6 cm²SL-B301-1:4.2 cm²/2 cm²SL-B328: 4.2 cm²/2 cm²	LS-T106: 3.2 cm²LS-T107: 3.7 cm²LS-T108: 3.2 cm²	W-1095: 2.69cm²W-1098: 4.3cm²	SimilarNote 2
Delivery device	Direct illumination totissue	Direct illumination totissue	Direct illumination totissue	Same
Pulsing control	Finger switch	Finger switch	Finger switch	Same
Location for use	large areas (e.g. arms,legs) and small areas(e.g. lip)	Multiple hair removalareas, includingsmall areas (e.g.armpit, bikini lines)and large areas (e.g.arms, legs)	Face, lips, underarms,bilini lines, arms, legs,etc	Same
Safety and EMC	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 62471	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83IEC 62471	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83IEC 62471	Same
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

Comparison in Detail(s):

Note 1:

Althouqh the "Pulse duration" and "Enerqy density" of the subject device is slightly different from that of the predicate device, the values of the pulse duration and energy density of the subject device are within the range of the reference device. So, this difference will not raise any safety or effectiveness issue.

Note 2:

Although the "Spot size (size of treatment window)" of subject device is a little different from the predicate device, the difference in treatment window size is due to different designs. So, we believe that these differences will not affect the device's performance.

7. Test Summary

7.1 Non-Clinical Tests Performed

1) Electrical safety, and electromagnetic compatibility Test

Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:

IEC 60601-1 2020-08 Edition 3.2 Medical electrical equipment Part 1: General requirements for basic . safety and essential performance

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� IEC 60601-1-11 Edition 2.1 2020-07 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 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
� IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
� IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems.

2) Biocompatibility Test

The subject device is biocompatible for its intended use. They are complied with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Skin Irritation).

Software verification and validation 3)

Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.

4) Usability validation

Usability testing was conducted on the IPL Hair Removal, Model: SL-B287, SL-B329, SL-B301-1, SL-B328, which complies with IEC 62366-1 and IEC 60601-1-6.

7.2 Summary of Clinical Performance

Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.

8. Date of the summary prepared: May 7, 2024

9. Final Conclusion

The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device K232499 and K232124.

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.