Planar LED mate

K230362 · Shenzhen Leaflife Technology Co., Ltd. · OHT · Sep 11, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230362
• Device Name: Planar LED mate
• Applicant: Shenzhen Leaflife Technology Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Sep 11, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair.

Device Story

Planar LED mate is a prescription-use handheld device for removal of unwanted body and facial hair. It utilizes a diode LED light source (780-850 nm) to target melanin in hair follicles via selective photothermolysis. The device is powered by an external AC adapter and activated by a finger switch. A capacitive sensor ensures the device is in full contact with the skin before light emission occurs. The device features 5 levels of output intensity. It is intended for single-person use. By heating the hair follicle, the device damages the tissue to reduce hair growth. The healthcare provider prescribes the device, and the patient performs the treatment at home. The device provides a non-invasive method for hair reduction.

Clinical Evidence

No clinical data. Bench testing only, including performance testing for energy output accuracy, biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety, and usability/label comprehension studies.

Technological Characteristics

Diode LED light source (780-850 nm); 8mm x 8mm spot size; 9.5-25J/cm² output intensity; 108-320ms pulse duration. Powered by AC 100-240V. Capacitive skin contact sensor. Biocompatibility per ISO 10993-5/10. Electrical safety per ANSI/AAMI ES60601-1, IEC 60601-1-11. EMC per IEC 60601-1-2. Photobiological safety per IEC 62471 and IEC 60601-2-83.

Indications for Use

Indicated for the removal of unwanted body and/or facial hair in patients requiring prescription-use hair removal.

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

• SILKPRO Laser Hair Removal System (K142845)
• IPL Hair Removal Device (K222316)
• LED Therapy Device (K220103)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 11, 2023

Shenzhen Leaflife Technology Co., Ltd Cheng Qiang Regulatory Affairs Manager 4F, Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang Dist., Shenzhen, Guangdong 518116 China

Re: K230362

Trade/Device Name: Planar LED mate 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: GEX Dated: February 9, 2023 Received: February 10, 2023

Dear Cheng Qiang:

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.

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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 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). 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 [phone] or 301-796-7100).

Sincerely,

Tanisha L. Tanisha L. Hithe -2023.09.11 Hithe -S 13:30:31 -04'00' Tanisha Hithe, MS, MHS 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) K230362

Device Name Planar LED mate

Indications for Use (Describe)

The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------|--|
|----------------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for LEAFLIFE. The logo is written in a stylized font with the letters in blue and green. There is a green leaf above the letters. Below the company name is the company name written in Chinese.

# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

#### SUBMITTER l.

Shenzhen Leaflife Technology Co., Ltd 4F, Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang Dist., Shenzhen, China

Contact Person: Cheng Qiang

Position: Regulatory Affairs Manager

Phone: [phone]

Fax: [phone]

| Primary Contact Person: | Cheng Qiang |
|---------------------------|---------------------------------------|
| | Regulatory Affairs Manager |
| | Shenzhen Leaflife Technology Co., Ltd |
| | Tel: [phone] |
| | Fax: [phone] |
| | Phone: [phone] |
| | Email: [e-mail] |
| Secondary Contact Person: | Vini Zeng |
| | Regulatory Affairs Specialist |
| | Shenzhen Leaflife Technology Co., Ltd |
| | Tel: [phone] |
| | Fax: [phone] |

Email: [e-mail]

Date Prepared:

06/09/2023

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Image /page/4/Picture/1 description: The image shows the logo for LEAFLIFE. The logo is in blue and green, with the word "LEAFLIFE" in blue, stylized font. Above the word is a green arc with a leaf at the end, and below the word is a blue arc. Underneath the word "LEAFLIFE" are two Chinese characters.

#### II. PROPOSED DEVICE

| Trade Name: | Planar LED mate |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Model(s): | LH-LNIRS |
| Common Name: | Powered Laser Surgical Instrument |
| Classification Name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology (21 CFR 878.4810) |
| Regulation Class: | II |
| Product Code: | GEX |
| Review Panel: | General & Plastic Surgery |

### III. PREDICATE DEVICE

| Predicate device (Primary) | |
|----------------------------|---------------------------------------------------|
| 510(k) Number: | K142845 |
| Device Name: | SILKPRO Laser Hair Removal System |
| Manufacturer: | Wuhan Lotuxs Technology Company, Ltd. |
| Predicate device (1#) | |
| 510(k) Number: | K222316 |
| Device Name: | IPL Hair Removal Device |
| Manufacturer: | Shenzhen Goodwind Technology Development CO., LTD |
| Predicate device (2#) | |
| 510(k) Number: | K220103 |
| Device Name: | LED Therapy Device |
| Manufacturer: | Shenzhen Leaflife Technology Co., Ltd |

The predicates have not been subject to a design-related recall.

### IV. DEVICE DESCRIPTION

The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair. It utilizes a diode LED as a light source (780-850 nm). lt 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 emission activation is by finger switch.

The device contains a capacitive 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. The device is for single-person use only.

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Image /page/5/Picture/1 description: The image shows the logo for LEAFLIFE. The logo is in blue and green, and it features a stylized leaf. The word "LEAFLIFE" is written in a modern font, with the letters connected to each other. There is also some Chinese text below the word "LEAFLIFE".

The proposed Planar LED mate is equipped with a light depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in the hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and it can be transferred to the structure of hair stems (such as medulla, cortex, and hair cuticle). The Near infrared light can precisely target the melanin and apply the depilation treatment selectively. After the melanin absorbs Near infrared light energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.

The device has 5 level Output Intensity.

#### V. INTENDED USE

The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair.

## vi. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Planar LED mate (LH-LNIRS) emits light energy to reduce hair growth, although compared to the predicate devices there may be differences in wavelengths, pulse durations, treatment spot sizes, and energy intensities. Please refer to the following table for details:

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Image /page/6/Picture/0 description: The image shows the logo for LeafLife. The logo is in blue and green, and it features the word "LEAFLIFE" in a stylized font. There is a green leaf above the "F" in "LEAFLIFE", and a blue curved line below the word. Below the word "LEAFLIFE" are two Chinese characters.

| Item | Proposed Device | Predicate Device<br>K142845 (Primary) | Predicate Device (1#)<br>K222316 | Predicate Device (2#)<br>K220103 | Remark |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device name | Planar LED mate | SILKPRO | IPL Hair Removal Device | LED Therapy Device | / |
| Product model | LH-LNIRS | / | ZHFIPL-II, ZHF-IPL-III | LM-LNIRA, LM-LNIRB | / |
| K number | K230362 | K142845 | K222316 | K220103 | / |
| Product code | GEX | OHT | OHT | OHT | Same |
| Classification<br>regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| ltem | Proposed Device | Predicate Device<br>K142845 (Primary) | Predicate Device (1#)<br>K222316 | Predicate Device (2#)<br>K220103 | Remark |
| Intended Use | The Planar LED mate is a<br>prescription-use only device<br>intended for removal of<br>unwanted body and/or facial<br>hair. | SILKPRO is an over-the<br>counter device intended for<br>adjunctive use with shaving<br>for hair removal sustained<br>with periodic treatments.<br>SILKPRO is also intended for<br>permanent reduction in hair<br>regrowth defined as a<br>long-term, stable reduction<br>in hair counts following a<br>treatment regime. | The IPL Hair Removal<br>Device is an<br>over-the-counter device<br>intended for removal of<br>unwanted body hair. | The LED Therapy Device is<br>intended for hair removal,<br>permanent hair reduction<br>on all skin types<br>(Fitzpatrick skin type I-VI),<br>including tanned skin.<br>Permanent hair reduction<br>is defined as the<br>long-term, stable<br>reduction in the number<br>of hairs regrowing when<br>measured at 6, 9, and 12<br>months after the<br>completion of a treatment<br>regime. | Same |
| Prescription use<br>or not | Prescription use | Over-The-Counter Use | Over-The-Counter Use | Prescription use | Same |
| Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch | Same |
| Light Type | Diode LED | Diode laser | IPL | Diode LED | Similar |
| Light<br>Wavelength | 780-850 nm | 810 nm | 510-1100nm | 780-850 nm | Similar |
| Item | Proposed Device | Predicate Device<br>K142845 (Primary) | Predicate Device (1#)<br>K222316 | Predicate Device (2#)<br>K220103 | Remark |
| Spot size | 8mm×8mm | 9mm×9mm | ZHF-IPL-II: 3.6cm²<br>ZHF-IPL-III: 4.1cm² | (17mm*22mm) 3.74cm²<br>(LM-LNIRA) | Similar |
| Output<br>Intensity | 9.5-25J/cm² | 5J/cm², 10J/cm², 15J/cm²,<br>20J/cm², 25J/cm² | ZHF-IPL-II: 2.6~4.4J/cm²<br>ZHF-IPL-III: 2.4~3.7J/cm² | 1-100J/cm² | Similar |
| Pulse Duration | 108-320ms | / | 7.2~10.8ms | 3-400ms | Similar |
| Power Supply | AC 100-240V~ 50/60 Hz | AC 100~240V 50/60 Hz | | AC 220~240V 50/60 Hz<br>or<br>AC 100~120V 50/60 Hz | Similar |

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Image /page/7/Picture/0 description: The image shows the logo for Leaflife. The logo is a combination of text and a stylized leaf design. The text "LEAFLIFE" is written in a modern, sans-serif font, with the letters in blue and green. Above the text is a green leaf design, which is curved and stylized. Below the text are two Chinese characters in gray.

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Image /page/8/Picture/0 description: The image shows the logo for LEAFLIFE. The logo is a combination of text and a graphic. The text "LEAFLIFE" is written in a stylized font, with the top half of the letters in green and the bottom half in blue. Above the "F" is a green leaf, and to the right of the leaf are some green dots. Below the text is the Chinese translation of the name.

#### Discussion

The Planar LED mate (LH-LNRS) device, the K222316, devices are handheld devices, while the K220103 is a larger console device. The handheld designs allow them to be more easily transported and stored by users who can administer their own hair removal treatments. The wavelength range, pulse durations, and output intensities, of the Planar LED mate are similar to those the K142845 and K222316 devices, although difference may lead to some differences in the results seen with over-the-counter devices such as K142845 (diode laser) and K221316 (PL). The wavelength range characteristics of the Planar LED mate (LH-LNIRS) are considered to be essentially the same as the K220103 device, and while the maximum pulse duration are less, the Planar LED mate (LH-LNIRS) device's output characteristics are considered to be acceptable for this prescription-use only device for the intended use of hair removal.

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Image /page/9/Figure/0 description: The image shows the logo for LEAFLIFE. The logo is blue and green, and it features a stylized leaf. The word "LEAFLIFE" is written in blue, with a green line running through the middle of the letters. Above the word is a green leaf with a green arc. Below the word are two Chinese characters.

| Item | Proposed Device | Predicate Device<br>K142845 (Primary) | Predicate Device (1#)<br>K222316 | Predicate Device (2#)<br>K220103 | Remark |
|-------------------|----------------------------------------------------|------------------------------------------|-------------------------------------------------------|------------------------------------------|---------|
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | / | Same |
| Sensitization | No evidence of sensitization | No evidence of<br>sensitization | No evidence of<br>sensitization | / | Same |
| Irritation | No evidence of irritation | No evidence of irritation | No evidence of irritation | / | Same |
| Electrical Safety | Comply with ANSI/AAMI<br>ES60601-1, IEC 60601-1-11 | Comply with ANSI/AAMI<br>ES60601-1 | Comply with ANSI/AAMI<br>ES60601-1, IEC<br>60601-1-11 | Comply with IEC<br>60601-1. | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC<br>60601-1-2 | Comply with IEC<br>60601-1-2 | Comply with IEC<br>60601-1-2 | Same |
| Laser Safety | Comply with IEC<br>60601-2-83, IEC 62471 | Comply with IEC<br>60601-2-22, IEC 60825 | Comply with IEC<br>60601-2-83, IEC 62471 | Comply with IEC<br>60601-2-57, IEC 62471 | Similar |

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### VII. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:

ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ANSI/AAMI A2:2010/(R)2012, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

IEC 60601-2-83, 2019 Medical electrical equipment - Part 2-83: Requirements for the basic safety and essential performance of home light therapy equipment.

IEC 62471:2006, Photobiological safety of lamps and lamp systems.

ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)

ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization. (Biocompatibility)

Performance Testing for Energy Output Accuracy.

Software Verification and Validation Testing was conducted per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", and the level of concern was determined to be Moderate for the proposed device.

Usability and label comprehension study.

VIII. CLINICAL TEST CONCLUSION

No clinical study is included in this submission.

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Image /page/11/Picture/2 description: The image shows the logo for LEAFLIFE. The logo is composed of the word "LEAFLIFE" in a stylized font, with the top half of the letters in green and the bottom half in blue. Above the "L" is a green leaf. To the right of the word "LEAFLIFE" are two Chinese characters in gray.

## IX. CONCLUSIONS

The Planar LED mate (LH-LNIRS) device and predicate devices emit pulsed light to reduce hair growth, and the information provided in this premarket notification supports that the device is substantially equivalent and that it can be used safely and effectively as a prescription-use only device intended for removal of unwanted body and/or facial hair.