(123 days)
No
The description focuses on the hardware components and basic control logic using a Micro Controller Unit (MCU). There is no mention of AI, ML, or any algorithms that would suggest learning or complex pattern recognition. The control system appears to be based on pre-programmed parameters and feedback loops for power and temperature.
Yes.
The device is indicated for the "treatment of reflux of the saphenous veins associated with varicose veins and varicosities," which implies a therapeutic purpose. Additionally, the non-clinical data mentions compliance with "IEC 60601-2-22:2007+AMD1: 2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment," explicitly listing it as a therapeutic device.
No
The "Intended Use / Indications for Use" section states that the device is "indicated for the treatment of reflux of the saphenous veins," which describes a therapeutic rather than a diagnostic purpose.
No
The device description clearly outlines hardware components such as a diode laser, MCU, power supply, and optical fiber coupling system. The performance studies also reference standards related to electrical and laser equipment, indicating a physical 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 the "treatment of reflux of the saphenous veins associated with varicose veins and varicosities." This is a therapeutic treatment performed directly on the patient's body.
- Device Description: The device is a diode laser system designed to deliver laser energy for treatment. It does not involve the examination of specimens (blood, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic laser system.
N/A
Intended Use / Indications for Use
The "CHERYLAS-15N and CHERYLAS-20N" are indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Product codes
GEX
Device Description
Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1470mm. It features impact structure, high efficiency and long lifetime. Generally the beam shall be shamed as the big beam divergence of the laser from the diode. When the coaxiality of laser and fiber meet the requirements, the laser beam can be coupled efficiently into the fiber.
The block diagram shows how the diode laser system works. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system, it supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system. The system can test and calibrate power by the calibration and feedback unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
saphenous veins
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 data:
The Medical Diode Laser Systems (Model: CHERYLAS-15N, CHERYLAS-20N) conforms to applicable standards included below requirements.
- AAMI / ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R) 2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD),
- IEC60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests,
- IEC 60601-2-22:2007+AMD1: 2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment and
- IEC60825-1:2007 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
Conclusion: The non-clinical data support the safety of the device and the software verification and validation demonstrate that the Medical Diode Laser Systems (Model: CHERYLAS-15N, CHERYLAS-20N) device should perform as intended in the specified use conditions, and all the data demonstrate that the subject device perform comparably to the predicate device that is currently marketed for the similar intended use.
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
October 26, 2021
Wuhan Dimed Laser Technology Co., Ltd. Long Yang, COO Shenzhen Hlongmed Biotech Co., Ltd. 1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan Shenzhen, Guangdong 518054 China
Re: K211977
Trade/Device Name: Medical Diode Laser Systems 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: July 30, 2021 Received: August 6, 2021
Dear Long Yang:
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 mediation-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 Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211977
Device Name Medical Diode Laser Systems
Indications for Use (Describe)
The "CHERYLAS-15N and CHERYLAS-20N" are indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 (as required by 807.92(c))
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR & 807.92.
The assigned 510(K) number is:__K211977 Date of Summary: _2021.10.26
1. Submitter information
Submitter Name: Wuhan Dimed Laser Technology Co., Ltd.
Address: Room 311, 313, 315, Hubei Guozhi Patent Venture Incubator Building, 327-1
Minzu Avenue, Wuhan East Lake High-tech Development Zone, Wuhan, China
Contact Person and Title: Qiao Cheng/QMS & RA Manager
Tel: 0086-15827482600
Fax: 0086-027-59706608
Email: chelsey cheng@dimedlaser.com
2. Contact person
2.1 Primary Contact Person
Long Yang (COO)
Shenzhen Hlongmed Biotech Co.,Ltd.
1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan, Shenzhen, P.R.C
Tel: 0086-755-86664986
Fax: 0086-755-86664933
E-mail: yanglong@hlongmed.com
2.2 Secondarv Contact Person
4
Qiao Cheng(QMS & RA Manager)
Wuhan Dimed Laser Technology Co., Ltd.
Tel: 0086-15827482600
3. Device information
| Type of 510(k) submission | Traditional |
|---|---|
| Device name | Medical Diode Laser Systems |
| Model | CHERYLAS-15N, CHERYLAS-20N |
| Common name | Medical Diode Laser Systems |
| Review Panel | General & Plastic Surgery |
| Product Code | GEX |
| Regulation Number | 21 CFR 878.4810 |
| Device Class | II |
4. Predicate device information
| 510(k)number | K160549 |
|---|---|
| Device name | Medical Diode Laser Systems |
| Sponsor | Wuhan Gigaa Optronics Technology Co., Ltd |
| Product code | GEX |
5. Device Description
Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1470mm. It features impact structure, high efficiency and long lifetime. Generally the beam shall be shamed as the big beam divergence of the laser from the diode. When the coaxiality of laser and fiber meet the requirements, the laser beam can be coupled efficiently into the fiber.
5
Image /page/5/Figure/0 description: This image is a block diagram of a laser system. The diagram includes components such as a foot switch, remote interlock, power supply, MCU, current control, DC-DC power, working temperature control, temperature control system, laser diode, fiber, laser output, power calibration, information input, and LCD. The diagram shows the flow of power and control signals between the different components of the laser system.
The block diagram shows how the diode laser system works. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system, it supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system. The system can test and calibrate power by the calibration and feedback unit.
6. Intended use
The "CHERYLAS-15N and CHERYLAS-20N" are indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
6
7. Technological characteristics and Substantial Equivalence
Wuhan Dimed Laser Technology Co., Co., Ltd. believes the CHERYLAS-15N, CHERYLAS-20N described in this submission is substantially equivalent to the predicate device as follows:
| No. | Item of
Comparison | Predicate device | Subject device | Discussion |
|-----|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------|
| 1 | 510K Number | K160549 | K211977 | NA |
| 2 | Proprietary
Name | Medical Diode Laser
Systems | Medical Diode Laser
Systems | NA |
| 3 | Model | VELAS II-15D | CHERYLAS-15N;
CHERYLAS-20N | NA |
| 4 | Manufacturer | Wuhan Gigaa Optronics
Technology Co., Ltd. | Wuhan Dimed Laser
Technology Co., Ltd. | NA |
| 5 | Product picture | Image: Predicate device | Image: Subject device | NA |
| 6 | Classification
name | Powered Laser Surgical
Instrument | Powered Laser Surgical
Instrument | Same |
| 7 | Product Code | GEX | GEX | Same |
| 8 | Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| 9 | Intended use/
Indication for | The "VELAS II-15D" is
indicated for use in the | The “ CHERYLAS-15N
and CHERYLAS-20N ” | Same |
| | use | | | |
| | | treatment of reflux of
the saphenous veins
associated with varicose
veins and varicosities. | are indicated for the
treatment of reflux of the
saphenous veins
associated with varicose
veins and varicosities. | |
| 10 | Laser Type | diode laser | diode laser | Same |
| 11 | Components | Laser system,
Color touch screen,
Foot switch,
Power detector | Laser system,
Color touch screen,
Foot switch | Different |
| 12 | Wavelength | 1470nm | 1470nm | Same |
| 13 | Output power | VELAS II-15D: 1-15W | CHERYLAS-15N:
0.1W-15W;
CHERYLAS-20N:
0.1W-20W; | Similar |
| 14 | Operation
mode | CW, single pulse, repeat
pulse | CW, single pulse, repeat
pulse | Same |
| 15 | Pulse width | 10ms-2.5s | 10ms- 3s | Similar |
| 16 | Pulse repetition
rate | 0.2Hz-50Hz | 0.2Hz-50Hz | Same |
| 17 | Application /
Light delivery
system | It is recommended to use
the disposable
sterile fiber (K124003,
MED-Fibers, Inc.)
registered in U.S.A. | It is recommended to use
the disposable
sterile fiber (K124003,
MED-Fibers, Inc.)
registered in U.S.A. | Same |
| | | The parameters must meet | The parameters must | |
| | | the following | meet the following | |
| | | requirements: | requirements: | |
| | | •bare fiber, long as 3m | •bare fiber, long as 3m | |
| | | •Fiber core diameter: | •Fiber core diameter: | |
| | | 600μm | 600μm | |
| | | •NA ≥0.22 | •NA ≥0.22 | |
| | | • With SMA905 | • With SMA905 | |
| | | connector | connector | |
| | | •Single used | •Single used | |
| 18 | Aiming Beam | Diode laser of
635/532nm, power
max.