(90 days)
The LED Therapy Device is intended for hair removal, permanent hair reduction on all 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.
The LED Therapy Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode LED as a light source (780-850 nm). The LED light power is delivered to the treatment area via a LED hand piece. The emission LED is activated by a foot switch and a hand piece.
The proposed LED Therapy Device 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 provided text is a 510(k) summary for the Shenzhen Leaflife Technology Co., Ltd's LED Therapy Device. It details the device's characteristics and compares them to predicate devices, but it explicitly states that "No clinical study is included in this submission."
Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria, as no such study is presented in the document.
Here's what I can extract based on the provided text, primarily about the technical specifications and comparison:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study with acceptance criteria is provided, I cannot create such a table for performance against clinical endpoints. However, the document does compare technical characteristics to predicate devices. Here's a table focusing on the technical characteristics comparison, noting where they are "Same," "Similar," or "Discussion" (implying a difference that the manufacturer argues does not impact substantial equivalence):
| Item | Proposed Device (Reported Characteristic) | Predicate Device K202980 (Primary) | Remark |
|---|---|---|---|
| Intended Use | Hair removal, permanent hair reduction on all skin types (I-VI), including tanned skin. | Hair removal, permanent hair reduction on all skin types (I-VI), including tanned skin. | Same |
| Product Code | OHT | GEX (Predicate K120737 & K181568 are OHT) | Same (with K181568) |
| Classification Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Prescription Use | Prescription use | Prescription use | Same |
| Laser Type | Diode LED | Diode laser | Discussion 1 |
| Laser Classification | Risk Group 3 | Class IV | Discussion 1 |
| Laser Wavelength | 780-850 nm | 808 nm | Discussion 1 |
| Spot Size | (17mm 22mm) for LM-LNIRA, (17mm 17mm) for LM-LNIRB | (12mm 12mm) 1.44 cm² | Discussion 2 |
| Fluence | 1-100 J/cm² | 1-100 J/cm² | Same |
| Frequency | 1-10 Hz | 1-10 Hz | Same |
| Pulse Duration | 3-400 ms | 5-400 ms | Similar |
| Patient Contact Materials | Sapphire in handpiece | Sapphire in handpiece | Same |
| Cytotoxicity | No Cytotoxicity (non-clinical test) | No Cytotoxicity | Same |
| Sensitization | No evidence of sensitization (non-clinical test) | No evidence of sensitization | Same |
| Irritation | No evidence of irritation (non-clinical test) | No evidence of irritation | Same |
| Electrical Safety | Comply with ANSI/AAMI ES60601-1 (non-clinical test) | Comply with ANSI/AAMI ES60601-1 | Same |
| EMC | Comply with IEC 60601-1-2 (non-clinical test) | Comply with IEC 60601-1-2 | Same |
| Laser Safety | Comply with IEC 60601-2-57, IEC 62471 (non-clinical test) | Comply with IEC 60601-2-22, IEC 60825 (Predicate K181568 is IEC 60601-2-57, IEC 62471) | Similar |
2. Sample sized used for the test set and the data provenance:
Not applicable as no clinical study or test set for performance evaluation is mentioned. The non-clinical tests mentioned are for safety and technical standards compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical study or ground truth for performance evaluation is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no clinical study or test set for performance evaluation 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 as no clinical study, MRMC study, or AI component is mentioned. This is a physical LED therapy device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is a physical LED therapy device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable as no clinical study or ground truth for performance evaluation is mentioned. Non-clinical tests were conducted to verify compliance with safety and electrical standards.
8. The sample size for the training set:
Not applicable as no clinical study or AI model requiring a training set is mentioned.
9. How the ground truth for the training set was established:
Not applicable as no clinical study or AI model requiring a training set is mentioned.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
April 12, 2022
Shenzhen Leaflife Technology Co., Ltd Cheng Qiang Regulatory registration supervisor 4F,Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang Dist., Shenzhen, Guangdong 518116 China
Re: K220103
Trade/Device Name: LED Therapy Device (Planar LED/Planar LED mini) 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: January 6, 2022 Received: January 12, 2022
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 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.
Purva Pandya 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) K220103
Device Name
LED Therapy Device (Planar LED/ Planar LED mini)
Indications for Use (Describe)
The LED Therapy Device is intended for hair removal, permanent hair reduction on all 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.
| 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) |
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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, RP China 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 |
Date Prepared:
01/06/2022
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Image /page/4/Picture/0 description: The image shows the logo for LEAFLIFE. The logo is in blue and green, with the word "LEAFLIFE" in blue, with a green line above the "F" and "E". Above the word is a green arc with a leaf at the top. Below the word is the Chinese translation of the word in gray.
II. PROPOSED DEVICE
| Trade Name: | LED Therapy Device |
|---|---|
| Common Name: | Powered Laser Surgical Instrument |
| Classification Name: | Powered Laser Surgical Instrument (21 CFR 878.4810) |
| Regulation Class: | II |
| Product Code: | OHT |
| Review Panel: | General & Plastic Surgery |
III. PREDICATE DEVICE
| Predicate device (Primary) | Laser Therapy Device, Model LM-L808A: K202980 |
|---|---|
| Predicate device | TRIA Laser Hair Removal System, Model TRIA: K120737 |
| Predicate device | IPL Salon Hair Reduction System, Model F60001K181568 |
The predicates have not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The LED Therapy Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode LED as a light source (780-850 nm). The LED light power is delivered to the treatment area via a LED hand piece. The emission LED is activated by a foot switch and a hand piece.
The proposed LED Therapy Device 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.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for LEAFLIFE. The logo has the word "LEAFLIFE" in blue, with a green arc above the word. There is a green leaf on the right side of the arc. Below the word "LEAFLIFE" are two Chinese characters in gray.
V. INTENDED USE
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.
vi. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The LED Therapy Device (LM-LNIRA, LM-LNIRB) is substantially equivalent to the cleared predicate device.
The LED Therapy Device (LM-LNIRA, LM-LNIRB) has the same intended use, and similar technological characteristics such as fluence, wavelength, spot size, and pulse duration, etc. with the predicates. Please refer to the following table for details:
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Image /page/6/Figure/0 description: The image shows the logo for LEAFLIFE. The logo is a combination of text and a graphic element. 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 text is a green leaf, and to the right of the leaf are some green bubbles. Below the text are some Chinese characters.
| Item | Proposed Device | Predicate DeviceK202980 (Primary) | Predicate DeviceK120737 | Predicate DeviceK181568 | Remark |
|---|---|---|---|---|---|
| Device name | LED Therapy Device(Planar LED/ Planar LED mini) | Laser Therapy Device | TRIA Laser Hair RemovalSystem (TRIA) | IPL Salon Hair ReductionSystem | / |
| Product model | LM-LNIRA, LM-LNIRB | LM-L808A | TRIA | F60001 | / |
| K number | On pending | K202980 | K120737 | K181568 | / |
| Product code | OHT | GEX | GEX | OHT | Same |
| Classificationregulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Item | Proposed Device | Predicate DeviceK202980 (Primary) | Predicate DeviceK120737 | Predicate DeviceK181568 | Remark |
| Intended Use | The LED Therapy Device isintended for hair removal,permanent hair reduction on allskin types (Fitzpatrick skin typeI-VI), including tanned skin.Permanent hair reduction isdefined as the long-term, stablereduction in the number ofhairs regrowing when measuredat 6, 9, and 12 months after thecompletion of a treatmentregime. | The Laser Therapy Device isintended for hair removal,permanent hair reductionon all skin types (Fitzpatrickskin type I-VI), includingtanned skin.Permanent hair reduction isdefined as the long-term,stable reduction in thenumber of hairs regrowingwhen measured at 6, 9, and12 months after thecompletion of a treatmentregime. | TRIA is anover-the-counter deviceintended for adjunctiveuse with shaving for hairremoval sustained withperiodic treatments. TRIAis also intended forpermanent reduction inhair regrowth defined as along-term, stablereduction in hair countsfollowing a treatmentregime. Permanent hairreduction is defined aslong term, stablereduction in the numberof hairs regrowing whenmeasured out to 6, 9, and12 months after thecompletion of thetreatment regimen. | The IPL Salon HairReduction System (Model:F60001) is an over theCounter device intendedfor the removal ofunwanted body and/orfacial hair in adults. It isalso intended forpermanent reduction inunwanted hair.Permanent hair reductionis defined as the long-termstable reduction in thenumber of hairsre-growing whenmeasured at 6. 9. and 12months after thecompletion of a treatmentregimen. | Same |
| Prescriptionuse or not | Prescription use | Prescription use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Configuration | Main Unit | Main Unit | Main Unit | Main Unit | Same |
| Hand piece | Handpiece | / | Finger switch | Same | |
| Item | Proposed Device | Predicate DeviceK202980 (Primary) | Predicate DeviceK120737 | Predicate DeviceK181568 | Remark |
| Foot Control | Foot Control | / | / | Same | |
| Laser Type | Diode LED | Diode laser | Diode laser | Xenon Arc Flashlamp | Discussion1 |
| LaserClassification | Risk Group 3 | Class IV | Class IV | Exempt group | Discussion1 |
| LaserWavelength | 780-850 nm | 808 nm | 800nm +/-20%(640nm-960nm) | 475nm~1200nm | Discussion1 |
| Spot size | (17mm22mm)(LM-LNIRA)(17mm17mm)(LM-LNIRB) | (12mm*12mm) 1.44cm² | $Φ$ 10mm (Round) | Treatment Area (regularwindow): 3.025 [cm²]Treatment area (facialadapter): 1.72 [cm²] | Discussion2 |
| Fluence | 1-100J/cm² | 1-100J/cm² | 6J/cm², 10J/cm², 14J/cm²,18J/cm², 22J/cm² | Level 1: 8.62JLevel 2: 9.45JLevel 3: 10.64JLevel 4: 11.48JLevel 5: 12.70J | Same |
| Frequency | 1-10Hz | 1-10Hz | / | / | Same |
| Pulse Duration | 3-400ms | 5-400ms | / | 11-12ms | Similar |
| Item | Proposed Device | Predicate DeviceK202980 (Primary) | Predicate DeviceK120737 | Predicate DeviceK181568 | Remark |
| Power Supply | AC 220 | AC 220 | 100~240V,50/60Hz | 100-240 VAC, 50/60Hz | Discussion3 |
| Dimension | 430mm x 500mm x 870mm(LM-LNIRA)408mm x 460mm x 593mm(LM-LNIRB) | 650mm x 430mm x 315mm | / | 14369.543mm(HWD) | Discussion3 |
| Weight | 30kg (LM-LNIRA)24kg (LM-LNIRB) | 22kg | / | 650g | Discussion3 |
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Image /page/7/Figure/0 description: The image shows the logo for LEAFLIFE. The logo is in blue and green, with a stylized leaf above the "L". The text "LEAFLIFE" is in blue, with a green line running through the middle of each letter. Below the text is a blue curved line. There is also some text in another language below the English text.
{8}------------------------------------------------
Image /page/8/Figure/0 description: The image shows the logo for LEAFLIFE. The logo features the word "LEAFLIFE" in blue and green, with a green leaf above the "F". There are also some Chinese characters below the word "LEAFLIFE".
{9}------------------------------------------------
Image /page/9/Figure/1 description: The image shows the logo for LEAFLIFE. The logo is blue and green, and it features a stylized leaf and the word "LEAFLIFE" in a modern font. There is also some text in another language below the word LEAFLIFE. The logo is clean and simple, and it conveys a sense of nature and life.
Discussion 1
The proposed device is different in Laser Classification, Laser Wavelength, and Laser Safety test standard from the predicate device. Mainly because of these differences caused by the inconsistency of Laser Type, this difference can be proved by non-clinical test There is no security impact. The difference that mainly affects performance may exist in the difference in Laser Wavelength can be verified by the Predicate device (K120737), Predicate device (K181568) and the wavelength range of light absorbed by melanin to prove that there is no effect on performance. Therefore, this difference will not affect the substantial equivalency.
Discussion 2
The proposed device is different in Spot Size only affects the area of treatment, not affecting the therapeutic effect, Therefore, this difference will not affect the substantial equivalency.
Discussion 3
{10}------------------------------------------------
Image /page/10/Picture/1 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 text is a green leaf graphic. Below the text is the Chinese translation of the name.
The proposed device is different in dimension and weight from the predicate device. By complying with ANS/AAMI ES60601-1, the Electrical Safety of the proposed device is determined to be accepted, this difference will not affect the substantial equivalency.
| Item | Proposed Device | Predicate DeviceK202980 (Primary) | Predicate DeviceK120737 | Predicate DeviceK181568 | Remark |
|---|---|---|---|---|---|
| Patient ContactMaterials | Sapphire in handpiece | Sapphire in handpiece | / | / | Same |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | / | / | Same |
| Sensitization | No evidence of sensitization | No evidence ofsensitization | / | / | Same |
| Irritation | No evidence of irritation | No evidence of irritation | / | / | Same |
| Electrical Safety | Comply with ANSI/AAMIES60601-1 | Comply with ANSI/AAMIES60601-1 | Comply with IEC 60601-1. | Comply with IEC60601-1. | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Same |
| Laser Safety | Comply with IEC60601-2-57, IEC 62471 | Comply with IEC60601-2-22, IEC 60825 | Comply with IEC60601-2-22, IEC 60825 | Comply with IEC60601-2-57, IEC 62471 | Similar |
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Image /page/11/Picture/0 description: The image shows the logo for LEAFLIFE. The logo is composed of the word "LEAFLIFE" in blue and green, with a green leaf above the "L". There is also some text in another language below the word "LEAFLIFE". The logo is simple and modern, and it conveys a sense of nature and health.
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 device. 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 60601-2-57:2011, 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 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 Spot Size Accuracy and Energy Output Accuracy.
VIII. CLINICAL TEST CONCLUSION
No clinical study is included in this submission.
IX. SUBSTANTIALLY EQUIVALENT (SE) CONCLUSION
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
§ 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.