(257 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices. The description focuses on the hardware components and intended use of a laser hair removal system.
No.
The device's intended use is hair removal and permanent hair reduction, which are aesthetic and cosmetic procedures, not medical treatments for a disease or condition. While the predicate device is named "Diode Laser Therapy Machine," the "therapy" in that name might refer to the application of light energy for hair removal, rather than for treating a medical condition. Without further information about a therapeutic indication for the current device, it is not considered a therapeutic device.
No
The device is intended for hair removal and permanent hair reduction, which are treatment procedures, not diagnostic functions. It does not identify or analyze a medical condition.
No
The device description explicitly lists hardware components such as a Handpiece, Touch screen, Emergency stop switch, Key switch, LED screen, and Foot switch, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "hair removal, permanent hair reduction on all skin types". This is a physical treatment applied directly to the body, not a test performed on samples taken from the body.
- Device Description: The device is described as a "surgical device" and its components are related to delivering laser energy to the skin (handpiece, touch screen, switches). This aligns with a therapeutic or cosmetic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically alter hair follicles using laser energy.
N/A
Intended Use / Indications for Use
The Diode Laser Hair Removal 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.
Product codes
GEX
Device Description
The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types.
There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The detailed difference shown in Table 1.
The main components of proposed device are shown in Table 2.
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
Not Found
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:
- IEC 60601-1:2012 Medical Electrical Equipment Part 1: General . Requirements For Basic Safety And Essential Performance;
- IEC 60601-2-22:2012, 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: 2007, Safety of laser products Part 1: Equipment classification . and requirements;
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General . requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests;
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for . Vitro cytotoxicity;
- ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for . irritation and delay-type hypersensitivity AMENDMENT 1: Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
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.
0
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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
April 6, 2020
Beijing Sano Laser S&T Development Co., Ltd % Huifang Zhao Consultant Microkn Business Consulting (Shanghai)Co., Ltd Room 1319, Block A, No 3699, Gonghexin Road, Jingan District Shanghai, 200435 CN
Re: K191970
Trade/Device Name: Diode 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: GEX Dated: March 5, 2020 Received: March 5, 2020
Dear Huifang Zhao:
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.
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
1
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 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,
Jessica Mavadia-Shukla, Ph.D. 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) K191970
Device Name Diode Laser Hair Removal System
Indications for Use (Describe)
The Diode Laser Hair Removal 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Date Prepared: 4/5/2020
1. Contact Information
1.1. Applicant
| Applicant Name: | Beijing Sano Laser S&T Development Co., Ltd. |
|---|---|
| Address: | Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi District, Beijing, China |
| Contact Person: | Hongbo Zhang |
| Title: | Manager |
| Telephone: | +86 10 57150601 |
| E-mail: | 360349720@qq.com |
1.2. Consultant
| Company: | Microkn Business Consulting (Shanghai) Co., Ltd. |
|---|---|
| Address: | Room 1319, Block A, No 3699, Gonghexin Road, Jingan |
| District, Shanghai, China | |
| Contact Person: | Huifang Zhao |
| Telephone: | +86 13961151430 |
| Email: | huifang.zhao@microkn.com |
2. Device information
| Trade Name: | Diode Laser Hair Removal System |
|---|---|
| Common Name: | Powered Laser Surgical Instrument |
| Model(s): | P-808, P-808L, P-808S, P-808W |
| Classification: | II |
| Product Code: | GEX |
| Regulation: | 21 CFR 878.4810 |
3. Legally Marketed Primary Predicate Device
| Product name: | Diode Laser Therapy Machine |
|---|---|
| 510(k) Number: | K161692 |
| Product Code: | GEX |
| Manufacture: | Beijing ADSS Development Co., Ltd |
4. Device Description
4
The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types.
There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The detailed difference shown in Table 1.
| Model | P-808 | P-808L | P-808S | P-808W |
|---|---|---|---|---|
| Size (cm) | 46x36x105 | 45x37x110 | 47x36x113 | 47x32x112 |
| Size of LED screen (inch) | 10 | 10 | 12 | 10 |
Table 1 the Difference of Models
The main components of proposed device are shown in Table 2.
| Table 2 Main Components of Proposed Device | ||
|---|---|---|
| Components | Function Description | Applied Model(s) |
|---|---|---|
| Handpiece | Deliver the laser to area to be treated | All Models |
| Touch screen | The user interface and for controlling of the system | All Models |
| Emergency stop switch | Stop the system in case of emergency situation | All Models |
| Key switch | Start the system | All Models |
| LED screen | Display the working status of the system, set the treatment parameters | All Models |
| Foot switch | control the laser output | All Models |
5
5. Indications for Use
The Diode Laser Hair Removal 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.
6. Substantially Equivalent (SE) Comparison
The Diode Laser Hair Removal System has been carefully compared to legally marketed devices with respect to intended use, configuration, principle of operation (Table 3), and performance specifications (Table 4).
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | SE |
| Regulation | |||
| Number | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | The Diode Laser Hair | ||
| Removal 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 Therapy | ||
| Machine 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, with | ||
| difference in | |||
| wording, | |||
| while the | |||
| actual | |||
| indications | |||
| are the | |||
| same. |
Table 3 General Comparison
6
| Configuration | |||
|---|---|---|---|
| Main Unit | Main Unit | SE | |
| Handpiece | Handpiece | SE | |
| Foot Control | Foot Control | SE | |
| Principle | |||
| of | |||
| Operation | Diode Laser | Diode Laser | SE |
Table 4 Performance Comparison
| ltem | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | SE |
| Laser Classification | Class IV | Class IV | SE |
| Laser Wavelength | 808 nm | 808 nm | SE |
| Spot Size | 1.44 cm² | 1.44 cm² | SE |
| Fluence | 10-120 J/cm2 | 2-120 J/cm2 | Discussion 1 |
| Frequency | 0.5-10 Hz | 1-10 Hz | SE |
| Power Supply AC | 110V/60Hz | 110 V/50 Hz-60 Hz | SE |
7
Discussion 1
The proposed device is different from the predicate device in fluence value, but the proposed device's fluence value range is included in the predicate's fluence value. Therefore, this difference will not affect the substantially equivalency.
Safety comparison has been done to validate the EMC, biocompatibility specification and safety of the device (Table 5).
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Patient Contact Materials and Biocompatibility | |||
| Patient Contact | |||
| Materials | Sapphire in handpiece and | ||
| handpiece tip (Stainless Steel) | Sapphire in handpiece and | ||
| handpiece tip (Stainless Steel) | SE | ||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | SE |
| Skin | |||
| sensitization | No evidence of sensitization | No evidence of sensitization | SE |
| Irritation | No evidence of irritation | No evidence of irritation | SE |
| EMC, Electrical and Laser Safety | |||
| Electrical safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | SE |
| EMC | 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 | SE |
Table 5 Safety Comparison
7. Non-Clinical Testing
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:
- IEC 60601-1:2012 Medical Electrical Equipment Part 1: General . Requirements For Basic Safety And Essential Performance;
- IEC 60601-2-22:2012, Medical Electrical Equipment Part 2-22: Particular .
8
Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment;
- IEC 60825-1: 2007, Safety of laser products Part 1: Equipment classification . and requirements;
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General . requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests;
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for . Vitro cytotoxicity;
- ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for . irritation and delay-type hypersensitivity AMENDMENT 1: Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
8. Clinical Test Conclusion
No clinical study is included in this submission.
9. Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.