IPL Hair Removal Device (SYL001AZ, SYL002AZ)

K253035 · Gu'An Yeolight Smart Electronics Co., Ltd. · OHT · Nov 19, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K253035
• Device Name: IPL Hair Removal Device (SYL001AZ, SYL002AZ)
• Applicant: Gu'An Yeolight Smart Electronics Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Nov 19, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

IPL Hair Removal Device (models SYL001AZ, SYL002AZ) provides hair reduction using Intense Pulsed Light (IPL) technology; energy source is Xenon Arc lamp. Device operates by emitting light pulses to target hair follicles below skin surface; does not involve cutting or pulling. Features include skin sensor to ensure full contact before pulse emission; integrated sapphire cooling function to manage treatment area temperature. Device is OTC, intended for home use; powered by external AC adapter; activation via finger switch. User observes output via light pulses; device provides hair reduction benefit. Differences in treatment levels between models; otherwise identical in function and structure.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, sensitization, irritation), electrical safety, electromagnetic compatibility, and photobiological eye safety testing. Software verification and validation confirmed all requirements met and hazards mitigated.

Technological Characteristics

IPL technology using Xenon Arc lamp; wavelength 510nm-1200nm; energy density 1.52-4.55 J/cm²; spot size 3.3 cm². Powered by AC 100V-240V adapter. Includes sapphire cooling. Biocompatibility per ISO 10993-5, -10, -23. Electrical safety per IEC 60601-1, -1-2, -1-11, -2-83. Eye safety per IEC 62471. Software/firmware controlled.

Indications for Use

Indicated for removal of unwanted body and/or facial hair in adults. Suitable for Fitzpatrick skin types I-V.

Regulatory Classification

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.

Predicate Devices

• IPL Hair Removal Device (K232499)
• IPL Hair Removal, (Model:OBT-02) (K213041)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

November 19, 2025

Gu'an Yeolight Smart Electronics Co., Ltd
% Bing Huang
RA Engineer
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center, No. 3101-90
Qianhai Road
Shenzhen, Guangdong 518082
China

Re: K253035
Trade/Device Name: IPL Hair Removal Device (SYL001AZ, SYL002AZ)
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 21, 2025
Received: September 22, 2025

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/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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253035 - Bing Huang
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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K253035 - Bing Huang
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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/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Tanisha Hithe
Digitally signed by
Tanisha Hithe
Date: 2023.11.19
11:00:12:00'00'

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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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253035 | |
| Device Name IPL Hair Removal Device (SYL001AZ, SYL002AZ) | |
| Indications for Use (Describe) The IPL Hair Removal Device 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) ☑ 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 [e-mail] | |
| "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." | |

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Gu'an Yeolight Smart Electronics Co., Ltd
510(k)s -510(k) Summary

# 510(k) Summary K253035

As required by 21 CFR Part 807.92.

Date: 2025-10-24

## I. Submitter

Gu'an Yeolight Smart Electronics Co., Ltd
Room 203 Building 1 beside No.12, Dongfang Street, High-Tech Zones, Gu'an, Langfang, Hebei Province
Post code: 065500
Tel.: [phone]

Junrui Liu
Title: Quality Assurance Department Manager
Tel.: [phone]
Email: [e-mail]

## II. Device

Name of Device: IPL Hair Removal Device
Model(s): SYL001AZ, SYL002AZ
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 & Reference Device

Predicate device:

| Manufacturer | Predicate Device | 510(k) Number | Cleared Date |
| --- | --- | --- | --- |
| Shenzhen Lescolton Electrical Appliance Co., Ltd. | IPL Hair Removal Device | K232499 | October 11, 2023 |
| Glan Electronics Co., Ltd. | IPL Hair Removal, (Model:OBT-02) | K213041 | November 18, 2021 |

## IV. Device Description

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Gu'an Yeolight Smart Electronics Co., Ltd
510(k)s -510(k) Summary

The IPL Hair Removal 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 IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains of main unit, power adapter and protective goggles.

The device contains a skin sensor to detect appropriate skin contact, if the light emitting window is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature by the Sapphire and provide the user with a better using experience.

There are SYL001AZ and SYL002AZ two models in this application. Their work principle, function, intended use, structure, appearance and composition are the same, with the only difference in treatment level.

The IPL Hair Removal Device has the components shown as following illustration:


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Gu'an Yeolight Smart Electronics Co.,Ltd

510(k)s -510(k) Summary

## V. Indications for Use

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

## VI. Comparison of Technological Characteristics With the Predicate Device

IPL Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, specifications, and performance:

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Gu'an Yeolight Smart Electronics Co., Ltd
510(k)s -510(k) Summary

| Comparison Elements | Subject Device | | Predicate Device 1 | Predicate Device 2 | Remark |
| --- | --- | --- | --- | --- | --- |
| 510(k) Number | Pending | | K232499 | K213041 | / |
| Trade name | IPL Hair Removal Device | | IPL Hair Removal Device | IPL Hair Removal | / |
| Model | SYL001AZ | SYL002AZ | LS-T106, LS-T107, LS-T108 | OBT-02 | / |
| Manufacturer | Gu'an Yeolight Smart Electronics Co.,Ltd | | Shenzhen Lescolton Electrical Appliance Co., Ltd | Glan Electronics Co., Ltd. | / |
| Regulation number | 21 CFR 878.4810 | | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | | OHT | OHT | Same |
| Device classification | Class II | | Class II | Class II | Same |
| Prescription or OTC | OTC | | OTC | OTC | Same |
| Indication for use/ Intended use | 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. | The IPL Hair Removal Device OBT-02 Version 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 re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults. | Same |
| Applicable skin | Fitzpatrick skin types I-V | | Fitzpatrick skin types I-V | Not publicly available | Same |
| Power supply | Out: AC 100V - 240V,50Hz/60Hz,1.5A
Input: DC 24V, 2.5A | | Not publicly available | AC Powered (100-240 V AC) | Same |

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Gu'an Yeolight Smart Electronics Co.,Ltd

510(k)s -510(k) Summary

| Comparison Elements | Subject Device | | Predicate Device 1 | Predicate Device 2 | Remark |
| --- | --- | --- | --- | --- | --- |
| Dimension | About 235mm × 105mm × 40mm | | LS-T106: 202.3±0.8*38*56.2 mm
LS-T107: 211.5*63.5*48.9 mm
LS-T108: 177.5*67*40 mm | 150*75*45 mm(H*W*D) | Different
Note 1 |
| Light source | Intense Pulsed Light | | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy medium | Xenon Arc lamp | | Xenon Arc lamp | Xenon Arc Flashlamp | Same |
| Wavelength range | 510nm-1200nm | | LS-T106: 610-1200nm
LS-T107: 560-1200nm
LS-T108: 470-1200nm | 510nm~1100nm | Similar
Note 2 |
| Energy density | Level 1: 1.52J/cm²
Level 2: 2.27J/cm²
Level 3: 3.03J/cm²
Level 4: 3.79J/cm²
Level 5: 4.55J/cm² | Level 1: 1.52J/cm²
Level 2: 3.03J/cm²
Level 3: 4.55J/cm² | LS-T106: 2.0-4.87J/cm²
LS-T107: 2.16-5.18J/cm²
LS-T108: 2.0-5.62J/cm² | Level 1: 1.5 J/cm²
Level 2: 1.9 J/cm²
Level 3: 2.6 J/cm²
Level 4: 3.7 J/cm²
Level 5: 4.0 J/cm² | Similar
Note 2 |
| Output energy | Level 1: 5.0J
Level 2: 7.5J
Level 3: 10J
Level 4: 12.5J
Level 5: 15J | Level 1: 5J
Level 2: 10J
Level 3: 15J | LS-T106: 8/10/13J (±20%)
LS-T107: 10/13/16J (±20%)
LS-T108: 8/12/15J (±20%) | Level 1: 4.5 J
Level 2: 5.7 J
Level 3: 7.8 J
Level 4: 11.1 J
Level 5: 12 J | Similar
Note 2 |
| Spot size
(Treatment area) | 3.3 cm² | | LS-T106: 3.2 cm²
LS-T107: 3.7 cm²
LS-T108: 3.2 cm² | 3.0 cm² | Same |
| Pulse duration | 1.1ms-8.25ms | | LS-T106: 0.64-2.4ms
LS-T107: 7.2-10.8ms
LS-T108: 6.8-10.2ms | 3 ms | Similar
Note 3 |
| Output intensity level | 5 levels | 3 levels | LS-T106: 3 levels
LS-T107: 3 levels
LS-T108: 3 levels | 5 levels | Same |
| Software/ Firmware/
Microprocessor | Yes | | Yes | Yes | Same |

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Gu'an Yeolight Smart Electronics Co.,Ltd

510(k)s -510(k) Summary

| Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
| --- | --- | --- | --- | --- |
| Control? | | | | |
| Electrical safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83 | Comply with IEC 60601-1 and IEC 60601-1-2, IEC60601-2-57 | Same |
| Eye safety | IEC 62471 | IEC 62471 | Not publicly available | Same |
| Biocompatibility | ISO 10993-5,
ISO 10993-10,
ISO 10993-23 | ISO 10993-5
ISO 10993-10 | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | Same |

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Gu'an Yeolight Smart Electronics Co., Ltd
510(k)s -510(k) Summary

## 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 is 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 September 4, 2020”, as recommended by FDA. The following testing was performed to, 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 irritation

### 2) Electrical Safety and EMC Safety

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

- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility
- IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION, 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 60601-2-83:2022, Medical Electrical Equipment – Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment

### 3) Eye Safety

- IEC 62471:2006 Photobiological safety of lamps and lamp systems

### 4) Software Verification and Validation

Software documentation consistent with *Basic Documentation* 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 devices.

## VIII. Conclusions

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Gu'an Yeolight Smart Electronics Co.,Ltd

510(k)s -510(k) Summary

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design and performance, it can be concluded that the IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate devices.

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