(213 days)
Not Found
No
The description focuses on the physical mechanism of action (selective photothermolysis using LED light) and basic safety features (capacitive sensor, power adapter, finger switch). There is no mention of AI, ML, image processing, or data-driven decision making. The software validation is for general software contained in a medical device, not specifically for AI/ML.
No
The device is intended for removal of unwanted hair, which is generally considered a cosmetic procedure rather than a therapeutic one. While it works by damaging hair follicle tissues, its purpose is not to cure, treat, mitigate, or prevent disease.
No
The device is intended for the removal of unwanted body and/or facial hair, which is a therapeutic rather than a diagnostic function. It works by damaging hair follicles using light energy, not by identifying or characterizing a medical condition.
No
The device description explicitly mentions hardware components such as a diode LED, external power adapter, finger switch, and capacitive sensor. It also details the physical mechanism of action involving light emission and skin contact. Furthermore, the performance studies include testing against hardware safety standards (IEC 60601 series) and biocompatibility standards (ISO 10993 series), which are not applicable to software-only devices. While software verification and validation are mentioned, this is for software contained in the medical device, not the device being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for removal of unwanted body and/or facial hair." This is a therapeutic or cosmetic purpose, not a diagnostic one.
- Device Description: The description details a light-based system for hair removal, focusing on the interaction of light with melanin in hair follicles. This mechanism is related to physical treatment, not the analysis of biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The device is clearly designed for a physical intervention (hair removal) and not for providing diagnostic information from in vitro analysis.
N/A
Intended Use / Indications for Use
The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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). 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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body and/or facial hair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
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 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 (1-800-638-2041 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
2
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 ( Select one or both, as applicable ) | |
|---|---|
| ---------------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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: 086-(0)17875910506
Fax: 086-0755-27215592
| Primary Contact Person: | Cheng Qiang |
|---|---|
| Regulatory Affairs Manager | |
| Shenzhen Leaflife Technology Co., Ltd | |
| Tel: 086-0755-27216609 | |
| Fax: 086-0755-27215592 | |
| Phone: 086-(0)17875910506 | |
| Email: cq@leaflife.cn | |
| Secondary Contact Person: | Vini Zeng |
| Regulatory Affairs Specialist | |
| Shenzhen Leaflife Technology Co., Ltd | |
| Tel: 086-0755-27216609 | |
| Fax: 086-0755-27215592 |
Email: zengvini@gmial.com
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 |
| 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.
5
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
K142845 (Primary) | Predicate Device (1#)
K222316 | Predicate Device (2#)
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
regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| ltem | Proposed Device | Predicate Device
K142845 (Primary) | Predicate Device (1#)
K222316 | Predicate Device (2#)
K220103 | Remark |
| Intended Use | The Planar LED mate is a
prescription-use only device
intended for removal of
unwanted body and/or facial
hair. | SILKPRO is an over-the
counter device intended for
adjunctive use with shaving
for hair removal sustained
with periodic treatments.
SILKPRO is also intended for
permanent reduction in hair
regrowth defined as a
long-term, stable reduction
in hair counts following a
treatment regime. | The IPL Hair Removal
Device is an
over-the-counter device
intended for removal of
unwanted body hair. | The LED Therapy Device is
intended for hair removal,
permanent hair reduction
on all skin types
(Fitzpatrick skin type I-VI),
including tanned skin.
Permanent hair reduction
is defined as the
long-term, stable
reduction in the number
of hairs regrowing when
measured at 6, 9, and 12
months after the
completion of a treatment
regime. | Same |
| Prescription use
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
Wavelength | 780-850 nm | 810 nm | 510-1100nm | 780-850 nm | Similar |
| Item | Proposed Device | Predicate Device
K142845 (Primary) | Predicate Device (1#)
K222316 | Predicate Device (2#)
K220103 | Remark |
| Spot size | 8mm×8mm | 9mm×9mm | ZHF-IPL-II: 3.6cm²
ZHF-IPL-III: 4.1cm² | (17mm*22mm) 3.74cm²
(LM-LNIRA) | Similar |
| Output
Intensity | 9.5-25J/cm² | 5J/cm², 10J/cm², 15J/cm²,
20J/cm², 25J/cm² | ZHF-IPL-II: 2.64.4J/cm²3.7J/cm² | 1-100J/cm² | Similar |
ZHF-IPL-III: 2.4
| Pulse Duration | 108-320ms | / | 7.210.8ms | 3-400ms | Similar | 50/60 Hz | AC 100
| Power Supply | AC 100-240V240V 50/60 Hz | | AC 220240V 50/60 Hz
or
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.
9
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
K142845 (Primary) | Predicate Device (1#)
K222316 | Predicate Device (2#)
K220103 | Remark |
|-------------------|----------------------------------------------------|------------------------------------------|-------------------------------------------------------|------------------------------------------|---------|
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | / | Same |
| Sensitization | No evidence of sensitization | No evidence of
sensitization | No evidence of
sensitization | / | Same |
| Irritation | No evidence of irritation | No evidence of irritation | No evidence of irritation | / | Same |
| Electrical Safety | Comply with ANSI/AAMI
ES60601-1, IEC 60601-1-11 | Comply with ANSI/AAMI
ES60601-1 | Comply with ANSI/AAMI
ES60601-1, IEC
60601-1-11 | Comply with IEC
60601-1. | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | Same |
| Laser Safety | Comply with IEC
60601-2-83, IEC 62471 | Comply with IEC
60601-2-22, IEC 60825 | Comply with IEC
60601-2-83, IEC 62471 | Comply with IEC
60601-2-57, IEC 62471 | Similar |
10
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.