(50 days)
Not Found
No
The summary describes a standard laser hair removal device based on selective photothermolysis and does not mention any AI or ML components or functionalities.
No.
The intended use is hair removal and permanent hair reduction, which are considered cosmetic procedures, not therapeutic.
No
The device is described as a "surgical device" intended for "hair removal" and "permanent hair reduction" by destroying hair follicles through selective photothermolysis. Its function is to treat a condition, not to diagnose one.
No
The device description explicitly lists numerous hardware components (diode laser source, hand piece, foot switch, etc.) and describes a physical mechanism of action (laser energy targeting melanin). While software verification and validation are mentioned, this is for the software contained within the hardware device, not a standalone software product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal and permanent hair reduction. This is a physical treatment applied directly to the body.
- Device Description: The device description details a laser system that targets melanin in hair follicles. This is a physical interaction with the body's tissues.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Reagents or kits for testing.
The device is clearly described as a surgical device used in dermatologic and general surgical procedures for a physical treatment (hair removal).
N/A
Intended Use / Indications for Use
The Laser 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.
Product codes
GEX
Device Description
The Laser Therapy Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser source (808 nm). The laser power is delivered to the treatment area via a laser hand piece. The emission laser is activated by a foot switch and a hand piece. The components of the Laser Therapy Device are mainly including main unit, hand piece, watered cup, overflow tube, foot switch, key, interlock, power cord, fuse, glasses and blindfold, etc.
The proposed Laser Therapy Device is equipped with laser depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in 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 laser can precisely target at the melanin and apply the depilation treatment selectively. After the melanin absorbs laser energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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 60601-2-22 Edition 3.1 2012-10, Medical Electrical Equipment - Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment.
IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
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 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.
No clinical study is included in this submission.
Key Metrics
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 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 19, 2020
Shenzhen Leaflife Technology Co., Ltd Albert Ou Regulatory Affairs Manager Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang District Shenzhen, Shenzhen 518116 China
Re: K202980
Trade/Device Name: Laser Therapy Device 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: September 27, 2020 Received: September 30, 2020
Dear Albert Ou:
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 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.
Purva Pandya Acting 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) K202980
Device Name Laser Therapy Device
Indications for Use (Describe)
The Laser 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.
| 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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3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
l. SUBMITTER
Shenzhen Leaflife Technology Co., Ltd C-401, C-402, C-403, 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: | Albert Ou |
|---|---|
| Regulatory Affairs Manager | |
| Shenzhen Leaflife Technology Co., Ltd | |
| Phone: 086-(0)13751890680 | |
| Email: Owen_newhorizon@outlook.com | |
| Secondary Contact Person: | Cheng Qiang |
| Regulatory registration supervisor | |
| Shenzhen Leaflife Technology Co., Ltd |
Tel: 086-0755-27216609
Fax: 086-0755-27215592
Email: cq@leaflife.cn
Date Prepared:
11/18/2020
4
II. PROPOSED DEVICE
| Trade Name: | Laser Therapy Device |
|---|---|
| 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 1# | Diode Laser Hair Removal System, Model HM-DL100:
K162659, Manufacturer: Shandong Huamei Technology
Co., Ltd |
|---------------------|----------------------------------------------------------------------------------------------------------------------------|
| Predicate device 2# | Diode laser hair removal device, Model PZ-806NVA:
K180353, Manufacturer: Zhengzhou PZ Laser Slim
Technology Co., Ltd |
The predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Laser Therapy Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser source (808 nm). The laser power is delivered to the treatment area via a laser hand piece. The emission laser is activated by a foot switch and a hand piece. The components of the Laser Therapy Device are mainly including main unit, hand piece, watered cup, overflow tube, foot switch, key, interlock, power cord, fuse, glasses and blindfold, etc.
The proposed Laser Therapy Device is equipped with laser depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in 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 laser can precisely target at the melanin and apply the depilation treatment selectively. After the melanin absorbs laser 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, which is written in blue font. Above the word LIFE is a green leaf. To the right of the logo is the number K202980 in black font.
V. INDICATIONS for USE
The Laser 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 Laser Therapy Device (LM-L808A) has same intended use, and technological characteristics such as fluence, laser 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 composed of the word "LEAFLIFE" in blue and green, with a green leaf above the "I" in "LIFE". Below the word "LEAFLIFE" is some text in another language. The logo is simple and modern, and it conveys a sense of nature and sustainability.
| Item | Proposed Device | Predicate Device
K162659 | Predicate Device
K180353 | Remark |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device name | Laser Therapy Device | Diode Laser Hair Removal System | Diode laser hair removal device | / |
| Product model | LM-L808A | HM-DL100 | PZ-806NVA | / |
| K number | On pending | K162659 | K180353 | / |
| Product code | GEX | GEX | GEX | SE |
| Classification
regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | The Laser 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. | The Diode Laser System 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. | The Diode Laser Hair Removal
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. | SE |
| Prescription use or
not | Prescription use | Prescription use | Prescription use | SE |
| Configuration | Main Unit
Hand piece | Main Unit
Handpiece | Main Unit
Handpiece | SE |
| Item | Proposed Device | Predicate Device
K162659 | Predicate Device
K180353 | Remark |
| | Foot Control | Foot Control | Foot Control | SE |
| Principle of
Operation | Diode laser | Diode laser | Diode laser | SE |
| Laser Type | Diode laser | Diode laser | Diode laser | SE |
| Laser Classification | Class IV | Class IV | Class IV | SE |
| Laser Wavelength | 808 nm | 808 nm | 808 nm | SE |
| Spot size | 1.44cm² | 1.44cm² | 1.44cm² | SE |
| Irradiance | 360 W/cm² | 0.7-347.8 W/cm² | 14-360 W/cm² | SE |
| Fluence | 1-100J/cm² | 1-120J/cm² | 1-100J/cm² | SE |
| Frequency | 1-10Hz | 0.5-15Hz | 1-20Hz | Discussion |
| Pulse Duration | 5-400ms | 5-400ms | 10-400ms | SE |
| Power Supply | AC 220240V 50/60 Hz120V 50/60 Hz | AC 110V/60Hz | AC 110V-230V/50-60Hz
or
AC 100
2000VA | Discussion |
| Dimension | 650mm x 430mm x 315mm | 450mm x 550mm x 380mm | 560mm x 380mm x 1180mm | Discussion |
| Weight | 22kg | 52kg | 60kg | Discussion |
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Image /page/7/Figure/0 description: The image shows the logo for LEAFLIFE. The logo features the word "LEAFLIFE" in blue, with a green line running through the middle of the letters. Above the word is a green leaf and a blue arc. Below the word is the Chinese translation of the word.
8
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, with a green line through the middle of the word. Above the word is a green leaf, and below the word is a blue curved line. Below the blue curved line are two Chinese characters.
Discussion
The proposed device is different in frequency range, power supply, dimension and weight from the predicate device.
9
Image /page/9/Picture/0 description: The image shows the logo for LEAFLIFE. The logo is blue and green, and it features a stylized leaf. The text "LEAFLIFE" is in blue, with a green line above it. Below the text is some smaller text in a different language. The logo is simple and modern, and it conveys a sense of nature and health.
| ltem | Proposed Device | Predicate Device
K162659 | Predicate Device
K180353 | Remark |
|------------------------------------------------|---------------------------------------|---------------------------------------|---------------------------------------|--------|
| Patient Contact Materials and Biocompatibility | | | | |
| Patient Contact
Materials | Sapphire in handpiece | Sapphire in handpiece | Sapphire in handpiece | SE |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | SE |
| Sensitization | No evidence of sensitization | No evidence of sensitization | No evidence of sensitization | SE |
| Irritation | No evidence of irritation | No evidence of irritation | No evidence of irritation | SE |
| EMC, Electrical and Laser Safety | | | | |
| Electrical Safety | Comply with ANSI/AAMI ES60601-1, | Comply with IEC 60601-1, | Comply with IEC 60601-1, | SE |
| | IEC 60601-2-22 | IEC 60601-2-22 | IEC 60601-2-22 | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | SE |
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Image /page/10/Picture/1 description: The image shows the logo for LEAFLIFE, which is written in blue and green. There is also some Chinese text below the logo. To the right of the logo is the text "K2029" in black.
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 60601-2-22 Edition 3.1 2012-10, Medical Electrical Equipment - Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment.
IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
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 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.
viii. CLINICAL TEST CONCLUSION
No clinical study is included in this submission.
11
IX. CONCLUSION
Based on the comparison and analysis above, the proposed device is determined to be as safe, as effective, and performs as well as the legally marketed predicate devices.