(105 days)
Not Found
No
The summary describes a standard laser hair removal system with a microcontroller and touch-screen interface, with no mention of AI or ML capabilities.
No
The device is described as a "hair removal system" and its intended use is "hair removal, permanent hair reduction." While it affects a physical change, it is not for the diagnosis, cure, mitigation, treatment, or prevention of disease, which typically defines a therapeutic device in a medical context.
No
The device is described as a "Diode Laser Hair Removal System" intended for hair removal and permanent hair reduction. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines hardware components such as a console, module, footswitch, cooling system, and touch-screen control panel, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is a laser system that is applied directly to the patient's skin for hair removal.
- The intended use and device description clearly state its purpose is hair removal and permanent hair reduction. This is a therapeutic/cosmetic application, not a diagnostic one.
- There is no mention of analyzing biological samples or providing diagnostic information.
The information provided describes a medical device used for a physical treatment, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Diode Laser Hair Removal System (RD-SLD600) 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 (RD-SLD600) is a professional platform, it is intended for the removal of unwanted hair and to effect stable, long-term hair reduction on all skin types (Fitzpatrick skin type I-VI).
The complete system consists of its console, module and a footswitch. The module is pressed against the patient's skin and a light pulse is delivered when the emitted button or the footswitch are activated. The crystal contact surface is cooled by the RD-SLD600's cooling system.
Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system's microcontroller through and LCD touch-screen.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
7.1 Clinical Tests
Clinical testing was not performed for the subject device as part of the submission.
7.2 Non-Clinical Tests
The following performance data are provided in support of the substantial equivalence determination:
- A Electrical Safety and Electromagnetic Compatibility (EMC)
ES60601-1:Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance;
IEC 60601-1-2: Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
IEC 60601-2-2, 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, Safety of laser products - Part 1: Equipment classification and requirements
A Biocompatibility
ISO 10993-5: Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10: Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
The conclusion from the testing is the device is safe and effective for its intended use, and performs as well or better than the predicate devices.
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 shows 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.
March 31, 2023
Shanghai Omni Laser Skinology Co., Ltd. % Helen Nan General Manager New Risen Enterprise Management Consulting Co., Ltd. Room 302, Building 3, Hangqian Mansion, Hangqian Street, Lucheng District Wenzhou, Zhejiang 325000 China
Re: K223778
Trade/Device Name: Diode Laser Hair Removal System (RD-SLD600) 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 6, 2023 Received: March 6, 2023
Dear Helen Nan:
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); 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,
Jianting Wang -S
Jianting Wang 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
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Indications for Use
Submission Number (if known)
Device Name
Diode Laser Hair Removal System (RD-SLD600)
Indications for Use (Describe)
Diode Laser Hair Removal System (RD-SLD600) 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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Image /page/3/Picture/0 description: The image shows a green shamrock with a purple arc behind it. The shamrock is a three-leaf clover, a symbol often associated with Ireland and St. Patrick's Day. The purple arc adds a touch of color and visual interest to the design. The image is simple and clean, making it easily recognizable.
K223778 510(k) Summary (As required by 21 CFR 807.92)
1.0 Submitter Information
| Company: | Shanghai Omni Laser Skinology Co., Ltd. |
|---|---|
| Address | Floor 3, Building 3, NO. 227, Mingqiang Road, Songjiang |
| District, Shanghai, 201612, CHINA | |
| Phone: | +86-021-54847192 |
| E-mail: | avril@omni-laser.com |
| Contact | Avril Ouyang |
| Title: | General Manager |
2.0 Device Information
| Trade/Device Name: | Diode Laser Hair Removal System |
|---|---|
| Model: | RD-SLD600 |
| Device: | Powered Laser Surgical Instrument |
| Review Panel: | General & Plastic Surgery |
| Product Code: | GEX |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | CFR 878.4810 |
| Device Class: | Class II |
3.0 Predicate Device Information
Predicate Device #1:
| Trade/Device Name: | Diode Laser Hair Removal System |
|---|---|
| 510k Number: | K162659 |
| Submitter: | Shandong Huamei Technology Co.,ltd |
Predicate Device #2:
| Trade/Device Name: | The Diode Laser Machine |
|---|---|
| 510k Number: | K211335 |
| Submitter: | Zhengzhou Bestview St Co., Ltd |
4.0 Indications for Use
Diode Laser Hair Removal System (RD-SLD600) 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.
5.0 Device Description
The proposed device, Diode Laser Hair Removal System (RD-SLD600) is a professional platform, it is intended for the removal of unwanted hair and to effect stable, long-term hair reduction on all skin types (Fitzpatrick skin type I-VI).
The complete system consists of its console, module and a footswitch. The module is
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Image /page/4/Picture/0 description: The image shows a green shamrock, a symbol often associated with Ireland and St. Patrick's Day. The shamrock has three leaves and is positioned in the center of the image. A light purple, semi-circular shape partially surrounds the shamrock, adding a subtle design element to the composition.
Shanghai Omni Laser Skinology Co., Ltd.
pressed against the patient's skin and a light pulse is delivered when the emitted button or the footswitch are activated. The crystal contact surface is cooled by the RD-SLD600's cooling system.
Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system's microcontroller through and LCD touch-screen.
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Image /page/5/Picture/1 description: The image shows a green shamrock inside of a circle. The circle is partially purple and partially white. The shamrock is in the center of the circle.
6.0 Comparison of Technological Characteristics with the Predicate Device
Table 1 - General Comparison
| Device Feature | Subject Device | Predicate Device #1 | Predicate Device #2 | Comparison |
|---|---|---|---|---|
| Name | Diode Laser Hair Removal | |||
| System RD-SLD600 | Diode Laser Hair Removal | |||
| System HM-DL100 | The Diode Laser Machine | |||
| BM-100 | - | |||
| Product Code | GEX | GEX | GEX | SE |
| Indications for use | Diode Laser Hair Removal | |||
| System (RD-SLD600) 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 Machine | |||
| (Model: BM-100) 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 | |||
| Configuration | Main Unit | Main Unit | Main Unit | SE |
| Handpiece | Handpiece | Handpiece | ||
| Foot Control | Foot Control | |||
| Principle of | ||||
| Operation | Diode Laser | Diode Laser | Diode Laser | SE |
| Device Feature | Subject Device | Predicate Device #1 | Predicate Device #2 | Comparison |
| Laser Type | Diode Laser | Diode Laser | Diode Laser | SE |
| Laser | ||||
| Classification | Class IV | Class IV | Class IV | SE |
| Wavelength | 808 nm | 808 nm | 808 nm | SE |
| Spot Size | 2.0 cm² (10*20mm) | 1.44 cm² | 2.25 cm² (15*15mm) | Discussion |
| Fluence | 40-120 J/ cm² | 1-120 J/ cm² | 0-120 J/cm² | SE |
| Irradiance | 1-300 W/cm² | 0.7-347.8 W/cm² | Not publicly available | SE |
| Frequency | 1-10 Hz | 0.5-15 Hz | 1-10 Hz | Discussion |
| Pulse Duration | 1-100 ms | 5-400 ms | 10-400 ms | Discussion |
| Power Supply | AC 100-240V, 50-60 Hz | AC 110V/60Hz | 220/110 VAC/50Hz-60Hz | SE |
| Dimension | 45.7cm * 38.5cm *104cm | 45cm * 55cm * 38cm | 112 cm * 42 cm * 60cm | Discussion |
| Weight | 50 KG | 52 KG | 63 KG | Discussion |
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Table 2 - Performance Comparison
Table 3 Safety Comparison
| Item | Subject Device | Predicate Device #1 | Predicate Device #2 | Comparison |
|---|---|---|---|---|
| Patient Contact | ||||
| Materials | K9 Crystal in handpiece | Sapphire in handpiece | handpiece | Discussion |
| 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 |
| Electrical Safety | Comply with IEC 60601-1 | |||
| IEC 60601-2-22 | Comply with IEC 60601-1, | |||
| IEC 60601-2-22 | Comply with IEC 60601-1, | |||
| IEC 60601-2-22 | SE |
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Image /page/7/Picture/0 description: The image shows a green shamrock with a purple arc behind it. The shamrock is a three-leaf clover, and it is the most prominent element in the image. The purple arc is positioned behind the shamrock, creating a sense of depth. The background is white.
| 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/8/Picture/0 description: The image shows a green shamrock with three leaves, which is a symbol of Ireland and Saint Patrick's Day. The shamrock is slightly blurred and has a white outline. A light purple arc is behind the shamrock, adding a sense of depth to the image. The background is white.
7.0 Discussion of Tests Performed
7.1 Clinical Tests
Clinical testing was not performed for the subject device as part of the submission.
7.2 Non-Clinical Tests
The following performance data are provided in support of the substantial equivalence determination:
- A Electrical Safety and Electromagnetic Compatibility (EMC)
ES60601-1:Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance;
IEC 60601-1-2: Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
IEC 60601-2-2, 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, Safety of laser products - Part 1: Equipment classification and requirements
A Biocompatibility
ISO 10993-5: Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10: Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
The conclusion from the testing is the device is safe and effective for its intended use, and performs as well or better than the predicate devices.
8.0 Software
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
9.0 Conclusion
The Diode Laser Hair Removal System (RD-SLD600) is as safe and effective as its predicate devices. The Diode Laser Hair Removal System (RD-SLD600) has the same intended use and same technological characteristics and specifications as its predicate devices. Thus, the Diode Laser Hair Removal System (RD-SLD600) is substantially equivalent to its predicate devices.