(166 days)
The "GBOX-15A/15B" are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), qynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only).
The "VELASII-30A/30B" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (UJrology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology Endovascular coagulation, Oral Surgery and Dental procedures, laser assisted lipolysis.
The "VELASII -60A/60B/60C" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue. Such as: Dermatology, Aesthetics, Plastic Surgery, Vascular Surgery, Podiatry, Endovenous Occlusion of the greater saphenous vein of the thigh in patients with superficial vein reflux.
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 are 810mm/980mm of GBOX-15A/15B, 810/980mm of VELAS II -30A/30B, 810/980/940nm of VELAS II -60A/60B/60C. 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 into " | " position. Immediately the power indicator will be green with the system fans working. At the same time, the LCD screen lights up as the picture shows below.
After finishing setting the parameters, press the "Ready" button and then the system will remind you to wear the safety goggles (protect wavelength from 800nm to 1100nm). At this time when you press down the footswitch, the laser will emit.
This document is a 510(k) Premarket Notification from Wuhan Gigaa Optronics Technology Company, Ltd. for their Medical Diode Laser Systems, including models GBOX-15A/15B, VELASII-30A/30B, and VELASII-60A/60B/60C. The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective.
The submission focuses on comparing the proposed devices to existing predicate devices rather than establishing novel acceptance criteria based on a specific clinical study of the proposed device's performance against a ground truth.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present "acceptance criteria" in the typical sense of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that a device must meet in a direct study against a ground truth. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing their specifications and intended uses. The "reported device performance" is largely framed within the context of these comparative specifications and adherence to recognized standards.
Here's a table summarizing the comparison, highlighting where the proposed devices align with or are similar to the predicate devices, which implicitly serves as the "acceptance criteria" for substantial equivalence.
| Feature | Acceptance Criteria (Predicate Device K082721 and K122567/K100558) | Reported Device Performance (Wuhan Gigaa Optronics Technology Co., Ltd. Medical Diode Laser Systems) | Comparison Conclusion (as stated in document) |
|---|---|---|---|
| General | |||
| Product Code | GEX | GEX | Same |
| Device Type | Diode Laser | Diode Laser | Same |
| Class | II | II | Same |
| Safety Classification | Class I Type B | Class I Type B | Same |
| Laser Class | 4 | 4 | Same |
| Operation Interface | Color LCD touch screen | Color LCD touch screen | Same |
| Microprocessor Control | Yes | Yes | Same |
| Indications for Use | Surgical applications requiring ablation, hemostasis, vaporization, excision, incision, and coagulation of soft tissue in specified medical specialties (aesthetic, gastroenterology, general surgery, genitourinary surgery, gynecology, neurosurgery, otolaryngology, ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery, and Laser Assisted Lipolysis for 980 nm). For some models, also includes use with endoscopic equipment and specific conditions like BPH, vascular lesions, hair removal, endovenous occlusion. | Covers the same range of surgical applications and medical specialties: ablation, hemostasis, vaporization, excision, incision, and coagulation of soft tissue, including specific uses like Laser Assisted Lipolysis and endoscopic applications. Indications for GBOX-15A/B are identical to LaserPro; for VELAS II-30A/B and VELAS II-60A/B/C, they are "same" or "similar" to JOULE and QUANTA systems. | Same or Similar. "The indications for use of 'VELAS II -30A/0B' are same to that of Quanta System QUANTA Diode Laser Family. The indications for use of 'VELAS II -60A/60B/60C' are same to that of JOULE 810/940/980 Multi-Platform System." Minor structural differences are deemed not to affect safety and effectiveness. |
| Technical Specifications (Examples) | |||
| Wavelength (GBOX-15A/B) | LaserPro 810: 810nm±10%; LaserPro 980: 980nm±10% | GBOX-15A: 810nm±10nm; GBOX-15B: 980nm±10nm | Similar. "Center wavelength is consistent, and GBOX wavelength accuracy is better than that of the predicate device." |
| Wavelength (VELAS II) | JOULE 810/940/980 (810nm, 940nm, 980nm); QUANTA 808/980 (808nm, 980nm) | VELAS II-30A, VELAS II-60A: 810nm $\pm$ 10nm; VELAS II-30B, VELAS II-60B: 980nm $\pm$ 10nm; VELAS II-60C: 940nm $\pm$ 10nm | Similar. "Center wavelength is consistent. Reasonable accuracy range of VELAS II does not affect safety and effectiveness." |
| Output Power (GBOX) | Predicate: 1-15W, 1-20W, 1-25W | GBOX: 1-15W | Similar. "Same as 1-15W. GBOX design output power has claimed to meet intended use." |
| Output Power (VELAS II) | JOULE: $\leq$ 100W; QUANTA: 30W | VELAS II-30A/B: 1-30W; VELAS II-60A/B/C: 1-60W | Similar. "Output power of 'VELAS II -30A/30B' is Same to that for 'QUANTA 808, QUANTA 980'. Output power range of 'VELAS II -60A/60B/60C' is contained in that of 'JOULE 810, JOULE 940, JOULE 980', and it has been designed to meet the intended use requirement claimed." |
| Pulse width (GBOX) | Predicate: 0.05s-10s | GBOX: $\le$ 2.5s | 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 width (VELAS II) | JOULE: $\le$ 2500ms (2.5s); QUANTA: 0.25-10000ms (0.25s-10s) | VELAS II: 10ms-2.5s | Similar. "Pulse width range of 'VELAS II -30A/30B, VELAS II -60A/60B/60C' is contained in that of the two types predicate device, and it has been designed to meet the intended use requirement claimed." |
| Components | Laser system, Color touch screen, Fiber and the handpiece, Foot switch, Power detector/calibrator | Laser system, Color touch screen, Fiber, Foot switch, Power detector/calibrator. (GBOX lacks handpiece, VELAS II does not explicitly list handpiece as a separate component distinct from fiber) | Similar. "Handle as the laser transmission system, should be used with optical fiber. So GBOX only uses fiber as the laser transmission system does not affect the safety and effectiveness." (Similar statement for VELAS II). |
| Power Supply | Predicate K082721: 100-240 VAC, 540VA max, 50/60Hz; Predicate K122567: 230VAC, 50/60Hz; Predicate K100558: 100-240VAC, 50-60Hz, 350VA | GBOX: 100-240VAC, 200VA, 50-60Hz; VELAS II-30A/B: 100-240VAC, 50/60Hz, 350VA; VELAS II-60A/B/C: 100-240VAC, 50/60Hz, 650VA | Similar. "Only rated power is different, not affect safety and effectiveness." |
| Sterility | Non-sterile (main engine) | Non-sterile (main engine), but fiber is sterile for single use. | Similar. "Fiber steriled for single use of GBOX (and VELAS II) is more effective to ensure the safety of patients." |
| Standards Compliance | IEC60601-1, IEC60601-1-2, IEC60601-2-22, IEC60825-1, ISO10993-1, ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11 | IEC60601-1, IEC60601-1-2, IEC60601-2-22, IEC60825-1, ISO10993-1, ISO10993-5, ISO10993-10 (For VELAS II, also ISO10993-4 and ISO10993-11 are listed in Section 9 Non-Clinical Tests) | Same (referring to adherence to these specific standards for safety and performance testing). |
2. Sample size used for the test set and the data provenance
The document describes non-clinical tests performed on the "GBOX" and "VELAS II" Medical Diode Laser Systems for safety and performance in accordance with various IEC and ISO standards. It also mentions "software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Test Set: No explicit "test set" in the context of clinical data (e.g., patient cases, retrospective or prospective) is described for evaluating device performance against primary clinical endpoints. The testing described is primarily engineering and bench testing to demonstrate compliance with general safety and performance standards and comparison to predicate device specifications.
- Sample Size: Not applicable in the context of a clinical test set. The non-clinical tests would have involved specific units of the device.
- Data Provenance: The tests were performed by the manufacturer, Wuhan Gigaa Optronics Technology Co., Ltd. The document does not specify a country of origin for the non-clinical test data other than the manufacturer's location in China. The "tests" here refer to regulatory compliance and engineering evaluations, not clinical trials with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as the submission is not based on a clinical study requiring ground truth establishment by experts. The "ground truth" for this submission is effectively the established safety and performance profile of the predicate devices and compliance with recognized international standards for medical electrical equipment and laser products.
4. Adjudication method for the test set
Not applicable. There is no clinical test set requiring expert adjudication described in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical diode laser system, not an AI-powered diagnostic or interpretive tool that would involve "human readers" or "AI assistance" in the sense of image analysis or diagnostic support. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm or AI system for diagnostic or interpretive purposes. It's a surgical laser system where the performance is physical (e.g., power output, wavelength, tissue interaction) and its operation is directly controlled by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is primarily:
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices to which the proposed devices are compared.
- Compliance with Recognized Standards: Adherence to international standards for medical electrical equipment, laser safety, and biological evaluation (e.g., IEC 60601 series, IEC 60825-1, ISO 10993 series).
- Engineering and Performance Specifications: The technical specifications (e.g., wavelength, output power, pulse width) are tested against internal design requirements and predicate device specifications.
There is no mention of ground truth established via expert consensus, pathology, or outcomes data from a clinical trial for the proposed device itself. The claim of "Substantial Equivalence" relies on demonstrating that the proposed device is sufficiently similar to devices already found safe and effective.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2015
Wuhan Gigaa Optronics Technology Company, Ltd Nie Xinxing Regulation Control Manager Hi-Tech Medical Device Industrial Park 818 Gauxin Avenue 5.6/f Unit A. B. Building B8 East Lake Development Zone Wuhan. CHINA 430206 Hubei
Re: K151890
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: November 27, 2015 Received: November 27, 2015
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
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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 (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.
Binita S. Ashar -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
K151890
Device Name
Medical Diode Laser Systems
Indications for Use (Describe)
The "GBOX-15A/15B" are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), qynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only).
The "VELASII-30A/30B" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (UJrology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology Endovascular coagulation, Oral Surgery and Dental procedures, laser assisted lipolysis.
The "VELASII -60A/60B/60C" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue. Such as: Dermatology, Aesthetics, Plastic Surgery, Vascular Surgery, Podiatry, Endovenous Occlusion of the greater saphenous vein of the thigh in patients with superficial vein reflux.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section 5 - 510(k) Summary
Date of Summary Preparation: August 06, 2015
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: GBOX-15A/15B, VELAS II -30A/30B, VELAS II -60A/60B/60C Classification Panel: General & Plastic Surgery Product Code: GEX Device Classification: Class II
4. The Predicate Devices
LaserPro Diode Surgical Laser System, LaserPro 810, LaserPro 980 K082721 JOULE 810/940/980 Multi-Platform System, JOULE 810, JOULE 940, JOULE 980 K122567 Quanta System QUANTA Diode Laser Family, QUANTA 808, QUANTA 980 K100558
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 are 810mm/980mm of GBOX-15A/15B, 810/980mm of VELAS II -30A/30B, 810/980/940nm of
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VELAS II -60A/60B/60C. 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 into " | " position. Immediately the power indicator will be green with the system fans working. At the same time, the LCD screen lights up as the picture shows below.
After finishing setting the parameters, press the "Ready" button and then the system will remind you to wear the safety goggles (protect wavelength from 800nm to 1100nm). 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 "GBOX-15A" and "GBOX-15B" are in surgical applications requiring the hemostasis, ablation, vaporization, excision, and coagulation of tissue in medical specialties including: aesthetic (dermatology and plastic surgery), soft gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only).
Intended Use of Medical Diode Laser Systems "VELAS II-30A" and "VELAS II-30B" are in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (UJrology), Thoracic Surgery, Plastic Surgery Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, and Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology Endovascular coagulation, Oral Surgery and Dental procedures, laser assisted lipolysis.
Intended Use of Medical Diode Laser Systems "VELAS II-60A", "VELAS II-60B" and "VELAS II-60C" are in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue. Such as: Dermatology, Aesthetics, Plastic Surgery, Vascular Surgery, Podiatry, Endovenous Occlusion of the greater saphenous vein of the thigh in patients with superficial vein reflux.
7. Summary of Substantial Equivalence
Table 1: The difference between GBOX-15A/15B and Predicate LaserPro 810, LaserPro 980 (K082721)
| Proposed Device | Predicate device | Comparison | |
|---|---|---|---|
| 510k Number | K151890 | K082721 | ------ |
| Product Code | GEX | GEX | Same |
Table 1
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| Proprietary Name | Medical Diode Laser Systems | LaserPro Diode Surgical Laser System | |
|---|---|---|---|
| Model | GBOX-15A, GBOX-15B | LaserPro 810, LaserPro 980 | ------- |
| Manufacturer | Wuhan Gigaa OptronicsTechnology Co., Ltd. | PhotoMedex, Inc. | ------- |
| Indications for use | The Medical Diode Laser Systems “GBOX-15A/15B”are indicated for use in surgical applications requiring theablation, hemostasis, vaporization, excision, incision,and coagulation of soft tissue in medical specialties including:aesthetic (dermatology and plastic surgery),gastroenterology, general surgery, genitourinary surgery(urology), gynecology (GYN), neurosurgery, otolaryngology(ENT), ophthalmology, arthroscopy, podiatry,pulmonology, and thoracic surgery; and Laser AssistedLipolysis (980 nm only). | The PhotoMedex LaserPro 810, 940 and 980 SurgicalDiode Laser Systems, (and the fiber delivery systemsand accessories used to deliver laser energy), areindicated for use in surgical applications requiring theablation, hemostasis, vaporization, excision, incision,and coagulation of soft tissue in medicalspecialties including: aesthetic(dermatology andplastic surgery), gastroenterology, generalsurgery, genitourinary surgery (urology), gynecology(GYN), neurosurgery, otolaryngology (ENT),ophthalmology, arthroscopy, podiatry, pulmonology, andthoracic surgery; and Laser Assisted Lipolysis (980 nmonly). | Same |
| Laser Type | diode laser | diode laser | Same |
| Components | Laser system, Color touch screen, Fiber, Foot switch,Power detector | Laser system, Color touch screen, Fiber and the handpiece,Foot switch, Power detector | Similar.Handle as the laser transmission system,should be used with optical fiber. So GBOXonly uses fiber as the laser transmissionsystem does not affect the safety andeffectiveness. |
| Wavelength | GBOX-15A: 810nm±10nmGBOX-15B: 980nm±10nm | LaserPro 810: 810nm±10%LaserPro 980: 980nm±10% | Similar.Center wavelength is |
| consistent, and GBOXwavelength accuracy isbetter than that of the | |||
| predicate device. | |||
| Output power | 1-15W | 1-15W1-20W1-25W | Similar.Same as 1-15W. GBOXdesign output powerhas claimed to meetintended use. |
| Operation mode | CW, single pulse, repeat pulse | CW, single pulse, repeat pulse | Same |
| Pulse width | $\le$ 2.5s | 0.05s -10s | Similar.Pulse width range ofthe device is containedin that of the predicatedevice, and it has beendesigned to meet theintended userequirement claimed. |
| Application / Lightdelivery system | Bare fiber, long as 3mFiber core diameter: 400µm,600μmNA $\ge$ 0.22With SMA905 connectorThe fiber is use on a singlepatient for onceBefore use must sterilecontact: fibers of 400μm, 600μmwith SMA905 connector;Non-contact: fibers and tips | SMA905 connectorSilica fiber core diametersgreater than or equal to 365microns and Fiber numericalaperture greater than or equal to0.29 NA | Similar. |
| Aiming Beam | Diode laser of 635nm, powermax. $<$ 5mW, adjustablebrightness | 635-650nm, adjustable intensity,either continuous or pulsed | Similar. |
| Laser Class | 4 | 4 | Same |
| Operation interface | Color LCD touch screen | Color LCD touch screen | Same |
| Power Supply | 100-240VAC, 200VA, 50-60Hz | 100-240 VAC, 540VA max,50/60Hz | Similar.Only rated power isdifferent, not affectsafety andeffectiveness. |
| Safety classification | Class I Type B | Class I Type B | Same |
| Dimensions | 215(W)*245(L)*315(H)mm | 228(W)*406(L)*356(H)mm | Similar.GBOX is more light |
| and portable. | |||
| Weight | 4 kg | 11.2kg | Similar.GBOX is more lightand portable. |
| Waterproof level | IPX1 | IPX1 | Same |
| FootswitchWaterproof level | IPX8 | IPX8 | Same |
| Standard | IEC60601-1IEC60601-1-2IEC60601-2-22IEC60825-1ISO10993-1ISO10993-4ISO10993-5ISO10993-10ISO10993-11 | IEC60601-1IEC60601-1-2IEC60601-2-22IEC60825-1ISO10993-1ISO10993-4ISO10993-5ISO10993-10ISO10993-11 | Same |
| Non- sterile | Main engine is Non- sterile, butfiber is sterile for single use. | Non- sterile | Similar.Fiber steriled for singleuse of GBOX is moreeffective to ensure thesafety of patients. |
| MicroprocessorControl | Yes | Yes | Same |
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Table 2: The difference between VELAS II -30A/30B, VELAS II-60A/60B/60C and Predicate JOULE 810, JOULE 940, JOULE 980 (K122567), QUANTA 808, QUANTA 980 (K100558)
| Table | 2 |
|---|---|
| ------- | --- |
| Proposed Device | Predicate device | Predicate device | Comparation | |
|---|---|---|---|---|
| 510k Number | K151890 | K122567 | K100558 | ------ |
| Product Code | GEX | GEX | GEX | Same |
| Proprietary Name | Medical Diode LaserSystems | JOULE 810/940/980Multi-Platform System | Quanta SystemQUANTA Diode LaserFamily | ------ |
| Model | VELAS II -30A, VELASII -30B, VELAS II -60A,VELAS II -60B, VELASII -60C | JOULE 810, JOULE940, JOULE 980 | QUANTA 808,QUANTA 980 | ------ |
| Manufacturer | Wuhan Gigaa OptronicsTechnology Co., Ltd | Sciton, Inc. | Quanta System SpA | ------ |
| Indications for use | The"VELAS II -30A/30B"are indicated for use in | The JOULE 810/940/980Multi-Platform Systemare indicated for use in | The Quanta SystemQUANTA Diode LaserFamily are indicated | Same.The indications for |
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applications surgical surgical applications for use in surgical of use requiring requiring the applications requiring "VELAS II -30A/3 the vaporization, incision, vaporization, incision, the vaporization, 0B" are same to excision, ablation. excision, ablation, incision, excision, that of Quanta cutting and hemostasis. ablation, cutting and System QUANTA cutting and hemostasis, or coagulation of soft or coagulation of soft hemostasis, or Diode Laser tissue in conjunction Family. tissue. Such as: coagulation of soft with endoscopic Dermatology, tissue in conjunction equipment for medical Aesthetics,Plastic with endoscopic The indications for specialist including: Surgery, Vascular equipment for medical use of Urology (BPH). Surgery, Podiatry, specialist including: "VELAS II -60A/6 0B/60C" are same Genitourinary Endovenous Occlusion Urology (BPH), (UJrology), Thoracic of the greater saphenous Genitourinary to that of JOULE Surgery, Plastic Surgery vein of the thigh in (UJrology), Thoracic 810/940/980 and Dermatology, patients with superficial Surgery, Plastic Surgery Multi-Platform Aesthetics including vein reflux. and Dermatology, System. vascular lesions and hair Aesthetics including removal, General vascular lesions and hair Surgery, removal, Ophthalmology, General Surgery, Podiatry. Orthopedics. Ophthalmology, Arthroscopy, Spinal Orthopedics, Podiatry, Gynecology, Arthroscopy , Spinal Surgery, Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Pulmonary Surgery, Gastroenterology, Neurosurgery(PLDD), Head/neck/ENT Gastroenterology, and Radiology Endovascular Head/neck/ENT and coagulation, Oral Radiology Endovascular Surgery and coagulation, Oral Dental procedures, laser assisted Surgery and Dental procedures, laser assisted lipolysis. lipolysis. The "VELAS II -60A/60B/60 C" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue. Such as: Dermatology, Aesthetics,
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| designed to meetthe intended userequirementclaimed. | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Plastic Surgery, VascularSurgery, Podiatry,Endovenous Occlusionof the greater saphenousvein of the thigh inpatients with superficialvein reflux. | Operation mode | CW, single pulse, repeatpulse | CW, single pulse, repeatpulse | CW, single pulse, repeatpulse | Same | ||||
| Laser Type | diode laser | diode laser | diode laser | Same | Pulse width | 10ms-2.5s | ≤2500ms | 0.25-10000ms | Similar.Pulse width rangeof"VELAS II -30A/30B,VELAS II -60A/60B/60C"iscontained in that ofthe two typespredicate device,and it has beendesigned to meetthe intended userequirementclaimed. |
| Components | Laser system, Colortouch screen, Fiber, Footswitch, Power calibrator | Laser system, Colortouch screen, Fiber, Footswitch, Power calibrator | Laser system, Colortouch screen, Fiber, Footswitch, Power calibrator | Similar.Handle as the lasertransmissionsystem, should beused with opticalfiber. SoVELAS II onlyuses fiber as thelaser transmissionsystem does notaffect the safetyand effectiveness. | Application / Lightdelivery system | Fiber core diameter:400µm, 600μmNA ≥0.22With SMA905 connectorThe fiber is use on asingle patient for onceBefore use must sterilecontact: fibers of 400µm,600µm with SMA905connector; Non-contact:fibers and tips | K122567Fiber optic withhandpiece | K100558Bare fier size:200,300,320,400,600,800,1000μm | Similar.VELAS II isdescribed moredetailed.Fiber core diameterrange of VELAS IIis contained in thatof the two typespredicate device,and it has beendesigned to meetthe intended userequirementclaimed. |
| Wavelength | VELAS II-30A, VELASII-60A: 810nm $\pm$ 10nmVELAS II-30B, VELASII-60B: 980nm $\pm$ 10nmVELAS II-60C:940nm $\pm$ 10nm | JOULE 810: 810nmJOULE 940: 940nmJOULE 980: 980nm | QUANTA 808: 808nmQUANTA 980: 980nm | Similar.Center wavelengthis consistent.Reasonableaccuracy range ofVELAS II does notaffect safety andeffectiveness. | Aiming Beam | Diode laser of635/532nm power max.< 5mW, adjustablebrightness. | --- | red (650nm), adjustable -<5mW | Similar.VELAS II has twotypes of indicationlight which notaffect safety andeffectiveness. |
| Output power | VELAS II-30A/ VELASII-30B: 1-30WVELAS II-60A, VELASII-60B, VELAS II-60C:1-60W | $\leq$ 100W | 30W | Similar.Output power of"VELAS II -30A/30B" is Same to thatfor "QUANTA808, QUANTA980".Output powerrange of"VELAS II -60A/60B/60C" iscontained in that of"JOULE 810,JOULE 940,JOULE 980", andit has been | Laser Class | 4 | 4 | 4 | Same |
| Operation interface | Color LCD touch screen | Color LCD touch screen | Color LCD touch screen | Same |
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| Wuhan Gigaa Optronics Technology Co., Ltd | ||
|---|---|---|
| Power Supply | VELAS II -30A, VELASII -30B: 100-240VAC,50/60Hz, 350VAVELAS II-60A, VELASII-60B, VELAS II-60C:100-240VAC, 50/60Hz,650VA | 230VAC, 50/60Hz | 100-240VAC, 50-60Hz,350VA | Similar.Only rated poweris different, notaffect safety andeffectiveness. |
|---|---|---|---|---|
| Safety classification | Class I Type B | Class I Type B | Class I Type B | Same |
| Dimensions | 400(W)*385(L)*200(H)mm | 762 (W)*406(L)*1092(H)mm | 330(W)*390(L)*250(H)mm | ---- |
| Weight | 12.9kg | ---------- | 8kg | ---- |
| Waterproof level | IPX1 | IPX1 | IPX1 | Same |
| FootswitchWaterproof level | IPX8 | IPX8 | IPX8 | Same |
| Standard | IEC60601-1IEC60601-1-2IEC60601-2-22IEC60825-1ISO10993-1ISO10993-5ISO10993-10 | IEC60601-1IEC60601-1-2IEC60601-2-22IEC60825-1ISO10993-1ISO10993-5ISO10993-10 | IEC60601-1IEC60601-1-2IEC60601-2-22IEC60825-1ISO10993-1ISO10993-5ISO10993-10 | Same |
| Non- sterile | Main engine is Non-sterile, but fiber is sterilefor single use. | Non- sterile | Non- sterile | Similar.Fiber steriled forsingle use ofVELAS II is moreeffective to ensurethe safety ofpatients. |
| MicroprocessorControl | Yes | Yes | Yes | Same |
8. Substantial Equivalence:
The proposed devices of GBOX-15A, GBOX-15B have the same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device. The differences only exist in The differences only exist in such contents: component of handpiece that do not influence use even if without it, wave rang of wavelength, output power, pulse width, and aiming beam that all can be controlled in range of application. These differences are slight and do not influence the effectiveness and safety of the device. According to the non-clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed devices are Substantially Equivalent (SE) to the predicate device which is US legally market device.
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The proposed devices of VELAS II-30A, VELAS II-30B, VELAS II-60A, VELAS II-60B, and VELAS II -60C have the same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device. The differences only exist in such contents: component of handpiece that do not influence use even if without it, wave rang of wavelength, output power, pulse width, and aiming beam that all can be controlled in range of application. These differences are slight and do not influence the effectiveness and safety of the device. According to the non-clinical and clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed devices are Substantially Equivalent (SE) to the predicate device which is US legally market device.
9. Non-Clinical Tests Performed:
The following testing was performed on the "GBOX" and "VELAS II" 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
ISO10993-1:2009/C1:2010, Biological evaluation of medical devices-Part 1: evaluation and testing within a risk management process.
ISO10993-4:2002/A1:2006, Biological evaluation of medical devices - Part 4: selection of tests for interactions with blood.
ISO10993-5:2009, Biological evaluation of medical devices-Part 5: tests for in vitro cytotoxicity.
ISO10993-10:2010, Biological evaluation of medical devices-Part10: tests for irritation and skin sensitization.
ISO10993-11:2006, Biological evaluation of medical devices - part 11: tests for systemic toxicity. 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.
10. Conclusion:
The proposed devices of GBOX-15A, GBOX-15B are determined to be Substantially Equivalent (SE) to the predicate device, LaserPro Diode Surgical Laser System, LaserPro 810/980 in respect of safety and effectiveness.
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The proposed devices of VELAS II-30A, VELAS II-60A, VELAS II-60A, VELAS II-60B, VELAS II-60C are determined to be Substantially Equivalent (SE) to the predicate device, JOULE 810/940/980 Multi-Platform System, JOULE 810, JOULE 940, JOULE 980 and Quanta System QUANTA Diode Laser Family, QUANTA 808, QUANTA 980 in respect of safety and effectiveness.
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§ 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.