(274 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the SILKPRO Laser Hair Removal System, based on the provided FDA 510(k) summary:
The provided document (510(k) summary) does not contain a detailed study design with specific acceptance criteria that demonstrate the device's clinical performance for "permanent hair reduction" backed by numerical efficacy data. Instead, it focuses on demonstrating substantial equivalence to a predicate device (TRIA Laser Hair Removal System) based on technological characteristics and safety standards.
However, it does mention an "intended use" that defines permanent hair reduction, which can be interpreted as the functional acceptance criterion the device aims to meet. It also describes a human factors usability study.
1. Table of Acceptance Criteria & Reported Device Performance
Note: The FDA 510(k) summary typically doesn't present a table of numerical acceptance criteria for clinical efficacy and reported device performance in the same way a clinical trial report would. Instead, it argues for substantial equivalence based on intended use and technological characteristics that are comparable to a predicate device, along with safety and usability studies.
| Acceptance Criteria (Inferred from Intended Use & Predicate Comparison) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Clinical Efficacy (Permanent Hair Reduction) | Implied to be equivalent to predicate: "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." The document asserts substantial equivalence to the TRIA Laser Hair Removal System (K090820), which has the same intended use. No specific numerical efficacy data (e.g., percentage hair reduction) for SILKPRO is provided in this document. |
| Safety and Electrical/Mechanical Performance | Meets recognized standards: The device claims compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-1, ISO 10993-5, and ISO 10993-10 for electrical, mechanical, thermal safety, electromagnetic compatibility, and biocompatibility. |
| Usability by Layperson | Demonstrated as acceptable: A Human Factors Usability study was conducted, showing that a layperson could understand the user manual, correctly use the device for hair removal, attach the power cord, recognize activation, correctly place and move the device, and understand contraindications. The study reported "no failures in terms of correct selection of appropriate site for treatment or correct application of laser to the targeted site." No numerical metrics (e.g., success rate, error rate) are provided. |
| Technological Characteristics | Comparable to predicate: Wavelength (810nm), Laser Type (Diode), Laser Material (GaAs), Operating Temperature/Humidity/Pressure, Power Supply. Differences in Max Energy Density (25J/cm² vs 22J/cm²), Energy Density levels, and Laser Beam dimensions were assessed as not affecting safety and effectiveness due to compliance with relevant IEC standards. |
2. Sample Size and Data Provenance
- Test Set (Human Factors Usability Study):
- Sample Size: The document does not specify the exact sample size for the Human Factors Usability study. It only states, "A Human Factors Usability study was conducted to demonstrate that a layperson was capable..."
- Data Provenance: Not explicitly stated, but typically, human factors studies for medical devices are conducted in a simulated or real-use environment within the country of manufacture or intended market. Given the manufacturer is Chinese, and it's for FDA submission, it could be either. It is a prospective study as it involved participants performing tasks with the device.
3. Number of Experts and Qualifications for Ground Truth
- Human Factors Usability Study: The document does not mention the use of "experts" to establish ground truth for this usability study in the context of clinical outcomes. The "ground truth" for usability was likely defined by the instructions in the user manual and objective observation of whether participants performed actions correctly.
- Clinical Efficacy (Permanent Hair Reduction): The document does not describe a clinical study for SILKPRO where experts established ground truth for hair reduction. The claim of "permanent hair reduction" is made by declaring substantial equivalence to a predicate device that likely had such studies.
4. Adjudication Method for the Test Set
- Human Factors Usability Study: Not specified. For usability studies, adjudication might involve multiple observers assessing participant performance against a checklist, but this detail is not provided.
- Clinical Efficacy: Not applicable as a primary clinical efficacy test set for SILKPRO is not described for this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study is not mentioned in this document. This type of study typically involves comparing physician performance (e.g., diagnostic accuracy) with and without an AI-assisted device. The SILKPRO device is a direct-to-consumer hair removal system, not a diagnostic tool requiring expert interpretation.
6. Standalone Performance Study
- For clinical efficacy (permanent hair reduction), a standalone algorithm-only or device-only performance study (meaning, clinical trial data for the SILKPRO device specifically measuring hair reduction) is not detailed or provided in this 510(k) summary. The summary relies on substantial equivalence to the predicate device for this claim.
- A Human Factors Usability study was performed, which assesses the device's performance in the hands of a lay user for its intended purpose. This is a form of standalone performance evaluation for usability.
7. Type of Ground Truth Used
- For Clinical Efficacy: The ground truth for the claim of "permanent hair reduction" for the predicate device (TRIA Laser Hair Removal System) would have historically been established through clinical measurements of hair counts at specified time points (6, 9, and 12 months post-treatment) following a treatment regimen. For SILKPRO, this 510(k) relies on the intended use matching the predicate and technological similarity.
- For Human Factors Usability Study: The ground truth was based on correct adherence to the instructions provided in the device's User Manual.
8. Sample Size for the Training Set
- This 510(k) summary does not describe any machine learning or AI components that would require a "training set" in the conventional sense. The device is a laser hair removal system, not an AI-driven diagnostic or treatment planning system. Therefore, this question is not applicable to the information provided.
9. How Ground Truth for Training Set Was Established
- As there is no mention of an AI or machine learning component requiring a training set, this question is not applicable.
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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
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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
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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 BiologicalIndustry Base, No.666 High-tech Avenue, East LakeHigh-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
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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 |
| WorkingEnvironment | Ambient Temperature: +5°C~+40°C;relative humidity: ≤80%;Atmospheric Pressure: 700_1060hPa |
| Storage/Transportation 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:
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| Table 1 Intended Use Comparison | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | --------------------------------- | -- |
| ID | Comparison Item | Proposed DeviceSILKPRO | Predicate DeviceTRIA |
|---|---|---|---|
| 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 DeviceSILKPRO | Predicate DeviceTRIA |
|---|---|---|---|
| 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 | ComparisonItem | Proposed DeviceSILKPRO | Predicate DeviceTRIA |
| 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 | AC100~240V, 50/60Hz, 60W | AC100 ~ 240V, 50/60Hz, 37VA |
| 5.2 | Input Voltage | 100~240V,50/60Hz | 100~240V,50/60Hz |
| 6 | Human factors (operation characteristic) | ||
| 6.1 | Usability | Button operation | Button operation, |
| 7 | Biocompatibility | ||
| 7.1 | Evaluation | Compliance withISO 10993-1ISO 10993-5ISO 10993-10 | Compliance withISO 10993-1ISO 10993-5ISO 10993-10 |
| 8 | Electrical & Mechanical safety& Thermal safety | ||
| 8.1 | Type of protectionagainst electricshock | Class I | Class I |
| 8.2 | Degree of protectionagainst harmfulingress of liquid | Ordinary equipment. | Ordinary equipment. |
| 8.3 | Evaluation | The electrical, mechanical andthermal safety evaluation isconducted as per therequirements of the standard | The electrical, mechanicaland thermal safety evaluationis conducted as per therequirements of the standard |
| ID | Comparison Item | Proposed DeviceSILKPRO | Predicate DeviceTRIA |
| IEC 60601-1. | IEC 60601-1. | ||
| 9 | Electromagnetic Compatibility | ||
| 9.1 | EMC Evaluation | Complying withIEC 60601-1-2 | Complying withIEC 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.
§ 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.