(274 days)
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on the laser technology and human factors usability.
Yes
The device is intended for permanent hair reduction by deactivating hair follicles, which aligns with the definition of a therapeutic effect.
No
The device is described as being for "hair removal" and "permanent hair reduction," and it deactivates hair follicles. It does not perform any diagnostic functions like detecting, monitoring, or analyzing medical conditions or diseases.
No
The device description explicitly states it "emits a pulse of laser light," indicating it is a hardware device that performs a physical action (emitting laser light) for hair removal. This is not a software-only device.
Based on the provided information, 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 to the body, not a test performed on biological samples (like blood, urine, or tissue) to diagnose a condition or provide information about a physiological state.
- Device Description: The device emits laser light to heat hair follicles. This is a physical mechanism of action, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Measuring analytes in biological fluids.
Therefore, the SILKPRO Laser Hair Removal System falls under the category of a therapeutic or cosmetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 hair reduction 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 regume.
Product codes
OHT
Device Description
The SILKPRO Laser Hair Removal System emits a pulse of laser light, which heats up the dark pigment inside the hair and deactivates the follicles in the skin that produce hair.
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
Over-The-Counter 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)
A Human Factors Usability study was conducted to demonstrate that a layperson was capable of reading the User Manual for the SILKPRO, understood the directions for use, and was able to correctly use the device for the intended use of hair removal as directed in the User Manual. This testing included correct attachment of the power cord, recognizing when the device was activated, correct placement and movement of the device at the targeted site, and understanding of when and where the device was not to be used. There were no failures in terms of correct selection of appropriate site for treatment or correct application of laser to the targeted site.
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/1 description: The image contains the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a graphic representation of human profiles facing to the right, suggesting a sense of community and service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2015
Wuhan Lotuxs Technology Company, Ltd. Ms. Wu Na Regulatory Manager R&D Building B1 of B, C, D Block, Wuhan National Biological Industry Base Wuhan, Hubei 430075 People's Republic of China
Re: K142845
Trade/Device Name: SILKPRO Laser Hair Removal System 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: May 28, 2015 Received: June 4, 2015
Dear Ms. Na:
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. 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.
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
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Page 2 - Ms. Wu Na
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142845
Device Name
SILKPRO Laser Hair Removal System
Indications for Use (Describe)
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 hair reduction 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 regume.
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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007_510 (k) Summary
4
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
August 24, 2014
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Wuhan Lotuxs Technology Co., Ltd. |
|---|---|
| Address: | R&D Building B1 of B, C, D Block, Wuhan National Biological |
| Industry Base, No.666 High-tech Avenue, East Lake | |
| High-tech Development Zone, Wuhan, P.R.C. | |
| Contact Name: | Wu Na |
| Telephone No.: | +86-27-87619668 |
| Fax No.: | +86-27-87515058 |
| Email Address: | na.wu@lotuxs.com |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a)
(2)]
| Trade Name: | SILKPRO Laser Hair Removal System |
|---|---|
| Common Name: | Powered laser surgical instrument |
| Classification: | 878.4810 Laser Instrument, Surgical, Powered |
| Product code: | OHT |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicates within this submission are as follows: TRIA Beauty, Inc., TRIA Laser Hair Removal System has been cleared by FDA
5
through 510(k) No.K090820 (Decision Date – Dec 23, 2009),
5. Description of the Device [21 CFR 807.92(a) (4)]
The SILKPRO Laser Hair Removal System emits a pulse of laser light, which heats up the dark pigment inside the hair and deactivates the follicles in the skin that produce hair.
6. Intended Use [21 CFR 807.92(a)(5)]
SILKPRO laser hair removal system adopts the 810nm diode laser, which targets on the hair follicle and slows the process of hair growth. It is used to remove unwanted hair of body. SILKPRO is also intended for permanent hair reduction 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.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Laser Type | Diode laser |
|---|---|
| Laser Material | GaAs |
| Wavelength | 810nm |
| Max Energy Density | 25J/cm² |
| Energy Density | 5J/cm²、10J/cm²、15J/cm²、20J/cm²、25J/cm² |
| Laser Beam | 9mm×9mm |
| Power Capacity | 100~240V, 50/60Hz |
| Electric Parameter | AC100 ~ 240V, 50/60Hz , 60W |
| Laser Type | Class 4 |
| Working | |
| Environment | Ambient Temperature: +5°C~+40°C; |
| relative humidity: ≤80%; | |
| Atmospheric Pressure: 700_1060hPa | |
| Storage/Transportat | |
| ion environment | Ambient Temperature: -40°C~+55°C; |
| relative humidity: ≤90%; | |
| Atmospheric Pressure: 700_1060hPa | |
| Weight | 700g |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
6
| Table 1 Intended Use Comparison | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | --------------------------------- | -- |
| ID | Comparison Item | Proposed Device
SILKPRO | Predicate Device
TRIA |
|----|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | 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. | TRIA is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. TRIA is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. |
8.2 Comparison table
Table 2 General Comparison
| ID | Comparison Item | Proposed Device
SILKPRO | Predicate Device
TRIA |
|----------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| 2 | General | | |
| 2.1 | Classification Name | Laser Instrument, Surgical,
Powered | Laser Instrument, Surgical,
Powered |
| 2.2 | Product Code | OHT | GEX |
| 2.3 | Regulation Number | 878.4810 | 878.4810 |
| 2.4 | Panel | General & Plastic Surgery | General & Plastic Surgery |
| 2.5 | Class | Class II | Class II |
| 3 | Performance | | |
| 3.1 | Laser Type | Diode laser | Diode laser |
| 3.2 | Laser Material | GaAs | GaAs |
| 3.3 | Wavelength | 810nm | 810nm |
| 3.4 | Max Energy Density | 25J/cm² | 22J/cm² |
| 3.5 | Energy Density | 5J/cm², 10J/cm², 15J/cm²,
20J/cm², 25J/cm² | 6J/cm², 10J/cm², 14J/cm²,
18J/cm², 22J/cm² |
| 3.6 | Laser Beam | 9mm×9mm | Φ 10mm (Round) |
| 4 | Physical Specifications | | |
| ID | Comparison
Item | Proposed Device
SILKPRO | Predicate Device
TRIA |
| Temperature | | | |
| 4.1 | Operating | +5°C~+40°C; | +5°C~+40°C; |
| 4.2 | Transport/ Storage | -40°C~+55°C | -40°C~+55°C |
| Relative humidity | | | |
| 4.3 | Operating | ≤ 80% | ≤ 80% |
| 4.4 | Transport/ Storage | ≤ 90% | ≤ 90% |
| Atmospheric Pressure | | | |
| 4.5 | Operating | 700_1060hPa | 700_1060hPa |
| 4.6 | Transport/ Storage | 700_1060hPa | 700_1060hPa |
| 5 | Power Supply | | |
| 5.1 | Power Capacity | AC100240V, 50/60Hz, 60W | AC100 ~ 240V, 50/60Hz, 37VA |240V,50/60Hz | 100~240V,50/60Hz |
| 5.2 | Input Voltage | 100
| 6 | Human factors (operation characteristic) | | |
| 6.1 | Usability | Button operation | Button operation, |
| 7 | Biocompatibility | | |
| 7.1 | Evaluation | Compliance with
ISO 10993-1
ISO 10993-5
ISO 10993-10 | Compliance with
ISO 10993-1
ISO 10993-5
ISO 10993-10 |
| 8 | Electrical & Mechanical safety& Thermal safety | | |
| 8.1 | Type of protection
against electric
shock | Class I | Class I |
| 8.2 | Degree of protection
against harmful
ingress of liquid | Ordinary equipment. | Ordinary equipment. |
| 8.3 | Evaluation | The electrical, mechanical and
thermal safety evaluation is
conducted as per the
requirements of the standard | The electrical, mechanical
and thermal safety evaluation
is conducted as per the
requirements of the standard |
| ID | Comparison Item | Proposed Device
SILKPRO | Predicate Device
TRIA |
| | | IEC 60601-1. | IEC 60601-1. |
| 9 | Electromagnetic Compatibility | | |
| 9.1 | EMC Evaluation | Complying with
IEC 60601-1-2 | Complying with
IEC 60601-1-2 |
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8.4 Discussion of Differences:
It is reasonable that there are some differences between our new device and its predicate. All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).
Review of ID 1 - Intended use, both are the same, so the SE is not affected.
Review of ID 2 - General, both are the same, so the SE is not affected.
Review of ID 3 - Performance, except three items as below, both are the same, so the SE is not affected.
- 3.4 Max Energy Density, The proposed device is 25J/cm² and the predicate device is 22J/cm², both of them comply with IEC 60601-2-22 and IEC 60825-1. Therefore, they can be considered substantially Equivalent in safety and effectiveness. So the SE is not affected.
- 3.5 Energy Density, The proposed device is 5J/cm², 15J/cm², 20J/cm², 25J/cm² and the predicate device is 6J/cm², 10J/cm², 14J/cm², 18J/cm², 22J/ cm2, both of them comply with IEC 60601-2-22 and IEC 60825-1. Therefore, they can be considered substantially Equivalent in safety and effectiveness. So the SE is not affected.
- 3.6 Laser Beam, The proposed device is 9mm×9mm and the predicate device is Ф 10mm (Round), both of them comply with IEC 60601-2-22 and IEC 60825-1. Therefore, they can be considered substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 4 - Physical Specifications, Temperature, Relative humidity and Atmospheric Pressure are comparable, so the SE is not affected
Review of ID 5 - Power Supply, both of them comply with IEC 60601-1 and IEC 60601-1-2. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
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Review of ID 6 - Human factors, both are the same, so the SE is not affected. Review of ID 7 - Biocompatibility, both are the same, so the SE is not affected. Review of ID 8 - Electrical & Mechanical safety& Thermal safety, both are the same, so the SE is not affected.
Review of ID 9 - EMC, both are the same, so the SE is not affected.
A Human Factors Usability study was conducted to demonstrate that a layperson was capable of reading the User Manual for the SILKPRO, understood the directions for use, and was able to correctly use the device for the intended use of hair removal as directed in the User Manual. This testing included correct attachment of the power cord, recognizing when the device was activated, correct placement and movement of the device at the targeted site, and understanding of when and where the device was not to be used. There were no failures in terms of correct selection of appropriate site for treatment or correct application of laser to the targeted site.
9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Wuhan Lotuxs Technology Co., Ltd. concludes that SILKPRO Laser Hair Removal System is substantially equivalent to predicate devices with regard to safety and effectiveness.