(86 days)
Not Found
No
The description focuses on standard IPL technology with sensors for safety and contact, and there is no mention of AI, ML, or related concepts like training/test sets.
No
The device is described as an over-the-counter hair reduction device for cosmetic purposes, not for treating any medical condition or disease.
No
The device is intended for hair removal, which is a treatment, not a diagnosis. It uses sensors to ensure safe and effective operation (skin contact and color detection), but these do not perform a diagnostic function.
No
The device description clearly outlines hardware components such as a Xenon Arc Flashlamp, capacitive sensor, skin sensor, and external power adapter. It also describes physical interactions like finger switch activation and skin contact detection. While software is mentioned for validation and hazard mitigation, the core functionality and components are hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Leaf Smooth Function: The Leaf Smooth is a device that uses Intense Pulsed Light (IPL) to reduce hair growth on the body and face. It works directly on the skin and does not involve analyzing any specimens taken from the body.
- Intended Use: The intended use clearly states "removal of unwanted body and/or facial hair," which is a cosmetic or aesthetic purpose, not a diagnostic one.
The information provided describes a medical device used for a physical treatment (hair reduction), not a device used for laboratory testing or analysis of biological samples.
N/A
Intended Use / Indications for Use
The Leaf Smooth is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Product codes
OHT
Device Description
The Leaf Smooth (LH-LIPLB) is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch.
The device contains a Xenon Arc Flashlamp, capacitive sensor to detect appropriate skin contact and a skin sensor to detect appropriate skin color. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only.
The Leaf Smooth has 6 levels 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
Over-the-counter device, personal use, end user
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 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 60601-1-11:2015, Medical electrical equipment - Part 1-11 General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
IEC 60601-2-57:2011, 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.
Software documentation consistent with moderate level 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.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 & 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.
November 19, 2021
Shenzhen Leaflife Technology Co., Ltd Cheng Qiang Regulatory Registration Supervisor 4 F,Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang District Shenzhen, Guangdong 518116 China
Re: K212697
Trade/Device Name: Leaf Smooth 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: August 18, 2021 Received: August 25, 2021
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 and Part 809); 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
2
Indications for Use
510(k) Number (if known) K212697
Device Name Leaf Smooth
Indications for Use (Describe)
The Leaf Smooth is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for LEAFLIFE. The logo is composed of the word "LEAFLIFE" in a stylized font, with the "LEAF" portion in blue and the "LIFE" portion in green. Above the word "LEAFLIFE" is a green leaf and a series of green dots. Below the word "LEAFLIFE" are two Chinese characters in gray.
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 registration supervisor | |
| Shenzhen Leaflife Technology Co., Ltd | |
| Phone: | 086-(0)17875910506 |
| Tel: | 086-0755-27216609 |
| Fax: | 086-0755-27215592 |
| Email: | cq@leaflife.com |
Date Prepared:
08/20/2021
4
Image /page/4/Picture/1 description: The image shows the logo for LEAFLIFE. The logo has the word LEAFLIFE in blue and green, with a green leaf above the letter "E". There are also some Chinese characters below the word LEAFLIFE. The logo is simple and modern, and it conveys a sense of nature and health.
II. PROPOSED DEVICE
| Trade Name: | Leaf Smooth |
|---|---|
| Model(s): | LH-LIPLB |
| Common Name: | Light Based Over-The-Counter Hair Removal |
| Classification Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Regulation Number: | 21 CFR 878.4810 |
| Regulation Class: | II |
| Product Code: | OHT |
| Review Panel: | General & Plastic Surgery |
III. PREDICATE DEVICE
| Predicate device 1# | IPL Home Use Hair Removal Device, Model D-1128:
K192432 |
|---------------------|------------------------------------------------------------|
| Predicate device 2# | IPL Salon Hair Reduction System, Model F60001:
K181568 |
| Predicate device 3# | iPulse SmoothSkin Gold Hair Removal System, K160968 |
The predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Leaf Smooth (LH-LIPLB) is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch.
The device contains a Xenon Arc Flashlamp, capacitive sensor to detect appropriate skin contact and a skin sensor to detect appropriate skin color. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only.
The Leaf Smooth has 6 levels output intensity.
5
Image /page/5/Picture/2 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 a blue arc under the word "LEAFLIFE", and some Chinese characters to the right of the arc. The logo is simple and modern, and it conveys a sense of nature and freshness.
V. INTENDED USE
The Leaf Smooth 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
The Leaf Smooth (LH-LIPLB) has same intended use as the predicate devices. Technological characteristics such as fluence, laser wavelength, spot size, and pulse duration, of the Leaf Smooth device are similar to those of the predicate devices.
6
Image /page/6/Figure/0 description: The image shows the logo for LEAFLIFE. The logo is in blue and green, with the word "LEAFLIFE" in blue and green. There is a green leaf above the word "LEAFLIFE". Below the word "LEAFLIFE" are two Chinese characters in gray.
| Item | Proposed Device | Predicate Device
K192432(Primary) | Predicate Device
K181568 | Predicate Device
K160968 | Remark |
|------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device name | Leaf Smooth (LH-LIPLB) | IPL Home Use Hair Removal
Device | IPL Salon Hair Reduction
System | iPulse SmoothSkin Gold | / |
| K number | On pending | K192432 | K181568 | K160968 | / |
| Product code | OHT | OHT | OHT | OHT | Same |
| Classification
regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Indications for
Use | The Leaf Smooth is an
over-the-counter device
intended for removal of
unwanted body and/or facial
hair. | IPL Home Use Hair Removal
Device is an over-the-counter
device intended for removal of
unwanted body and/or facial
hair | The IPL Salon Hair Reduction
System (Model: F60001) is
an over the Counter device
intended for the removal of
unwanted body and/or facial
hair in adults. It is also
intended for permanent
reduction in unwanted hair.
Permanent hair reduction is
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
regimen. | The iPulse SmoothSkin Gold
Hair Removal System is
indicated for the removal of
unwanted hair. The iPulse
Smoothskin Gold is also
indicated for the permanent
reduction in hair regrowth,
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 | OTC | OTC | OTC | OTC | Same |
| Item | Proposed Device | Predicate Device
K192432(Primary) | Predicate Device
K181568 | Predicate Device
K160968 | Remark |
| Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch | Same |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue | Same |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Wavelength
range | 475-1100 nm | 510-1100nm | 475-1200nm | 510-1100nm | Similar |
| Spot size | 3.8 $cm^2$ | 4.5 $cm^2$ , 2.0 $cm^2$ , 3.0 $cm^2$ | 3.02 $cm^2$
1.72 $cm^2$ | 3 $cm^2$ | Similar |
| Fluence | 4-6 J/ $cm^2$ | 2.0-4.0 J/ $cm^2$ , 2.5-4.5 J/ $cm^2$ | Max 5 J/ $cm^2$ | 3-6 J/ $cm^2$ | Similar |
| Pulse Duration | 2-10ms | 7.5-14ms | 11-12ms | 2-10ms | Similar |
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Image /page/7/Picture/0 description: The image shows the logo for LEAFLIFE. The logo is blue and green, with a stylized leaf above the text. The text is in a sans-serif font, and there is some Chinese text below the English text. The logo is simple and modern, and it conveys a sense of nature and life.
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Image /page/8/Picture/0 description: The image shows the logo for LEAFLIFE. The logo is in blue and green, with the word "LEAFLIFE" in blue and green letters. There is a green leaf above the "A" in LEAFLIFE. There is a blue curve below the "L" and "E" in LEAFLIFE. Below the word LEAFLIFE are two Chinese characters in gray.
| Item | Proposed Device | Predicate Device
K192432 | Predicate Device
K181568 | Predicate Device
K160968 | Remark |
|----------------------------------|-------------------------------------------------------|--------------------------------------------|--------------------------------------------|--------------------------------------------|--------|
| Biocompatibility | | | | | |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Sensitization | No evidence of 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 | No evidence of irritation | Same |
| EMC, Electrical and Laser Safety | | | | | |
| Electrical
Safety | Comply with ANSI/AAMI
ES60601-1,
IEC 60601-1-11 | Comply with IEC 60601-1,
IEC 60601-1-11 | Comply with IEC 60601-1,
IEC 60601-1-11 | Comply with IEC 60601-1,
IEC 60601-1-11 | 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 |
| Light Safety | Comply with IEC 60601-2-57,
IEC 62471 | Comply with IEC 60601-2-57,
IEC 62471 | Comply with IEC 60601-2-57,
IEC 62471 | Comply with IEC 60601-2-57,
IEC 62471 | Same |
9
Image /page/9/Picture/2 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 "L" and "E" in blue, the "A" and "F" in green, and the "L", "I", "F", and "E" in blue. Above the text is a green leaf with a curved line. Below the text is some Chinese characters.
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 60601-1-11:2015, Medical electrical equipment - Part 1-11 General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
IEC 60601-2-57:2011, 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.
Software documentation consistent with moderate level 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.
VIII. CLINICAL TEST CONCLUSION
No clinical study is included in this submission.
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Image /page/10/Picture/2 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 letters in blue and green. Above the text is a green leaf. Below the text are two Chinese characters in gray.
IX. SUBSTANTIALLY EQUIVALENT (SE) CONCLUSION
The Leaf Smooth device has the same intended use and similar technology to those of the predicate devices. Performance testing conducted on the Leaf Smooth device supports that the Leaf Smooth can be used safely and effectively for the indications for use stated above.
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.