(403 days)
No
The description focuses on the physical components and operation of a diode laser system, with no mention of AI or ML capabilities.
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.
No
The device is indicated for the "treatment of reflux of the saphenous veins," which indicates a therapeutic rather than a diagnostic purpose.
No
The device description explicitly details hardware components such as a diode laser system, working material, cavity resonator, power source, LCD screen, and footswitch, indicating it is a physical medical 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 for the treatment of reflux of saphenous veins. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a medical diode laser system used to emit laser energy. This is a physical treatment modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
Therefore, the "VELASI -15D" is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The "VELASI -15D" is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Product codes
GEX
Device Description
Medical diode laser systems are a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.
The medical diode laser systems for this unit is GaAlAs diode bar, and the wavelength is 1470nm of VELAS II-15D. It features impact structure, high efficiency and long lifetime. The beam divergence angle is too large lead to poor beam quality. In order to better meet the needs of Laser Diode practical applications, Laser Diode carried beam shaping is very necessary. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.
To start the laser unit, turn the main switch ON and turn the key switch clockwise to "I" position. The power indicator will turn green immediately with the system fans working. At the same time, the LCD screen lights up.
After the parameters setting is finished, press the "Ready" button and the system will remind you to wear the protective eyewear (protective wavelength is from 800nm to 1700mm). At this time when you press down the footswitch, the laser will emit.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was performed on the "VELAS II-15D" Medical Diode Laser Systems in accordance with the requirements of the design control regulations and established quality assurance procedures:
- IEC60601-1:2005+A1:2012+National differences of US ANSI/AAMI Medical electrical equipment-Part 1: General requirements for basic safety and essential performance Incorporates Amendment 1:2012; Incorporates National differences of US ANSI/AAMI ES60601-1:2005+C1:2009+A2:2010+A1:2012 Medical equipment-Part 1: General requirements for basic safety and essential performance Consolidated reprint C1:2009; Incorporates Amendment 2:2010; Incorporates Amendment 1:2012
- IEC60601-2-22:2007+A1:2012 Medical electrical equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Incorporates Amendment 1:2012
- IEC60601-1-2:2007 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC60825-1:2007 Safety of laser products-Part 1: Equipment classification and requirements
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three lines above them that resemble a stylized wing or flame.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2017
Wuhan Gigaa Optronics Technology Co., Ltd Nie Xinxing Regulation Control Manager 5, 6/F, Unit A, B, Building B8, Hi-tech Medical Device Industrial Park, #818 Gaoxin Avenue East Lake Development Zone, Wuhan, 430206 CN
Re: K160549
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: February 27, 2017 Received: March 6, 2017
Dear Nie Xinxing:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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
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,
Jennifer R. Stevenson -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) K160549
Device Name Medical Diode Laser Systems
Indications for Use (Describe)
The "VELASI -15D" is 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)
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5 - 510(k) Summary
Date of Summary Preparation: February 22, 2016 Date of Summary Revision: February 27, 2017
1. Submitter's Identifications
Submitter's Name: Wuhan Gigaa Optronics Technology Co., Ltd Address: 5, 6/F, Unit A, B, Building B8, Hi-Tech Medical Device Industrial Park, #818 Gaoxin Avenue, East Lake Development Zone, Wuhan 430206,China Contact Person: Nie Xin xing Contact Email Address: fdagigaalaser(@sohu.com Telephone: +86-27-67848871-8045 Fax: +86-27-67848873
2. Correspondent's Identifications
Correspondent's Name: Wuhan Gigaa Optronics Technology Co., Ltd Address: 5, 6/F, Unit A, B, Building B8, Hi-Tech Medical Device Industrial Park, #818 Gaoxin Avenue, East Lake Development Zone, Wuhan 430206, China Contact Person: Nie Xinxing Contact Email Address: fdagigaalaser(@sohu.com Telephone: +86-27-67848871-8045 Fax: +86-27-67848873
3. Name of the Device
Device Classification Name: POWERED LASER SURGICAL INSTRUMENT Product Name: POWERED LASER SURGICAL INSTRUMENT Trade Name: Medical diode laser systems Model: VELAS II -15D Classification Panel: General & Plastic Surgery Product Code: GEX Device Classification: Class II
4. The Predicate Devices
K082225 15W Ceralas D 1470nm Diode Laser, D1470
5. Device Description
Medical diode laser systems are a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.
The medical diode laser systems for this unit is GaAlAs diode bar, and the wavelength is 1470nm of VELAS II-15D. It features impact structure, high efficiency and long lifetime. The beam divergence angle is too large lead to poor beam quality. In order to better meet the needs of Laser
4
Diode practical applications, Laser Diode carried beam shaping is very necessary. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.
To start the laser unit, turn the main switch ON and turn the key switch clockwise to "I" position. The power indicator will turn green immediately with the system fans working. At the same time, the LCD screen lights up.
After the parameters setting is finished, press the "Ready" button and the system will remind you to wear the protective eyewear (protective wavelength is from 800nm to 1700mm). At this time when you press down the footswitch, the laser will emit.
6. Intended Use of Device
Intended Use of Medical Diode Laser Systems "VELAS II -15D" is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
7. Summary of Substantial Equivalence
| Proposed Device | Predicate device | Comparison | |
|---|---|---|---|
| 510k Number | ------- | K082225 | ------- |
| Product Code | GEX | GEX | Same |
| Proprietary | |||
| Name | Medical Diode Laser | ||
| Systems | 15W Ceralas D 1470nm | ||
| Diode Laser | ------- | ||
| Model | VELAS II -15D | D1470 | ------- |
| Manufacturer | Wuhan Gigaa Optronics | ||
| Technology Co., Ltd | Biolitec, Inc. | ------- | |
| Indications for | |||
| use | The "VELAS II -15D" is | ||
| indicated for use in the | |||
| treatment of reflux of | |||
| the saphenous veins | |||
| associated with varicose | |||
| veins and varicosities. | The device is indicated | ||
| for the treatment of | |||
| reflux of the saphenous | |||
| veins associated with | |||
| varicose veins and | |||
| varicosities. | Same | ||
| Laser Type | diode laser | diode laser | Same |
| Components | Laser system, Color | ||
| touch screen, Foot | |||
| switch, Power detector | Laser system, Color | ||
| touch screen, Fiber and | |||
| the handpiece, Foot | |||
| switch, Power detector | Similar. | ||
| Handpiece in D1470 as | |||
| the laser transmission | |||
| system used with | |||
| optical fiber together. | |||
| VELAS II -15D does | |||
| not equip with fiber and | |||
| handpiece, but | |||
| recommending a | |||
| disposable sterile fiber | |||
| (K124003, | |||
| MED-Fibers, Inc.) | |||
| registered in U.S.A, not | |||
| affect the safety and | |||
| effectiveness. | |||
| Wavelength | $1470nm\pm10nm$ | $1470nm\pm30nm$ | Similar. |
| Center wavelength is | |||
| consistent, and | |||
| wavelength accuracy of | |||
| VELAS II -15D is better | |||
| than that of the | |||
| predicate device. | |||
| Output power | 1-15W | 1-15W | Same |
| Operation mode | CW, single pulse, repeat pulse | CW, single pulse, repeat pulse | Same |
| Pulse width | 10ms-2.5s | 0.01s -60s | Similar. |
| Pulse width range of the | |||
| device is contained in | |||
| that of the predicate | |||
| device, and it has been | |||
| designed to meet the | |||
| intended use | |||
| requirement claimed. | |||
| Pulse repetition rate | 0.2Hz-50Hz | 0.01Hz-50Hz | Similar. |
| Pulse repetition rate is | |||
| slight similar, not affect | |||
| safety and effectiveness. | |||
| Application / | |||
| Light delivery | |||
| system | It is recommended to | ||
| use the disposable | |||
| sterile fiber (K124003, | |||
| MED-Fibers, Inc.) | |||
| registered in U.S.A. | |||
| The parameters must | |||
| meet the following | |||
| requirements: | |||
| • bare fiber, long as 3m | |||
| • Fiber core diameter: | |||
| 600μm | |||
| • NA ≥0.22 | |||
| • With SMA905 | |||
| connector | |||
| • Single used | Fiber diameter ≥ 360μm | Similar. | |
| VELAS II -15D is | |||
| described more detailed. | |||
| Fiber core diameter | |||
| range of VELAS II -15D | |||
| is contained in that of | |||
| the predicate device, | |||
| and it has been designed | |||
| to meet the intended use | |||
| requirement claimed. | |||
| Aiming Beam | Diode | ||
| laser of | |||
| 635/532nm, power max. |