(271 days)
(1) The Medical Diode Laser Systems, model: GBOX-6H, VELAS II-6H is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coaqulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The output wavelength of model GBOX-6H and VELAS II -6H is 1940nm.
(2) The Medical Diode Laser Systems, model: GBOX-10D, GBOX-12D is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endloscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The output wavelength of model GBOX-10D and GBOX-12D is 1470nm.
(3) The Medical Diode Laser Systems, model: GBOX-15D, VELAS II -15D is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The GBOX-15D, VELAS II - 15D is further indicated for laser assisted lipolysis. The output wavelength of model GBOX-15D and VELAS II -15D is 1470nm.
(4) The Medical Diode Laser Systems, model: VELAS Pro-30B15D is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. Medical Diode Laser Systems, model: VELAS Pro-30B15D is further indicated for laser assisted lipolysis. The output wavelength of model VELAS Pro-30B15D is 980nm or 1470nm.
The "Medical Diode Laser Systems", include model: GBOX-6H, VELAS II -6H, GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D, VELAS Pro-30B15D which consist of three main components: Main device; Foot switch; Accessories. 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 1940nm for GBOX-6H, VELAS II -6H; 1470nm for GBOX-10D, GBOX-12D, GBOX-15D, VELAS III-15D; 980nm or 1470nm for VELAS Pro-30B15D. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. 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 connector 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 provided document is a 510(k) summary for Medical Diode Laser Systems. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in terms of clinical performance. The document primarily discusses the similarity of the proposed device to predicate devices. Therefore, much of the requested information cannot be extracted directly from this type of regulatory submission.
Here's a breakdown of what can be inferred or explicitly stated:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria for clinical performance (e.g., specific efficacy rates or safety profiles) for the proposed device, nor does it report its performance against such criteria. Instead, it compares the technological characteristics of the proposed device to predicate devices. The "acceptance criteria" here are implicitly meeting the performance characteristics of the predicate devices to prove substantial equivalence.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (as compared to Predicate) |
|---|---|
| Indications for Use (GBOX-6H, VELAS II-6H): Surgical applications requiring vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for various medical specialists. | Substantially Equivalent (Same indications as K222701, covered by K193656) |
| Indications for Use (GBOX-10D, GBOX-12D): Surgical applications requiring vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for various medical specialists. | Substantially Equivalent (Same indications as K222701, covered by K160952) |
| Indications for Use (GBOX-15D, VELAS II-15D): Endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux; laser assisted lipolysis. | Substantially Equivalent (Same indications as K160952, covered by K222701) |
| Indications for Use (VELAS Pro-30B15D): Surgical applications requiring vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for various medical specialists; endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux; laser assisted lipolysis. | Identical to K240747 |
| Laser Type: Diode laser | Identical (Diode laser) |
| Wavelength (GBOX-6H, VELAS II-6H): 1940nm | Identical (1940nm) |
| Wavelength (GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D): 1470nm | Identical (1470nm) |
| Wavelength (VELAS Pro-30B15D): 980nm or 1470nm | Identical (980nm or 1470nm) |
| Output Power (GBOX-6H, VELAS II-6H): 1-6W | Similar (Predicate K222701 at 5W, Predicate K193656 up to 7.5W) |
| Output Power (GBOX-10D, GBOX-12D, GBOX-15D): GBOX-10D: 1-10W; GBOX-12D: 1-12W; GBOX-15D: 1-15W | Similar (Within scope of Predicate K222701: Max. 12W and Predicate K160952: Max. 15W) |
| Output Power (VELAS Pro-30B15D): 980nm: 30W; 1470nm: 15W | Identical (Same as K240747) |
| Pulse Width (GBOX-6H, VELAS II-6H): 10ms-10s | Similar (Predicate K222701: 10ms-30s; Predicate K193656: 10ms-10s) |
| Pulse Width (GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D): 10ms-10s | Similar (Predicate K222701: 10ms-30s; Predicate K160952: 10-990ms) |
| Pulse Width (VELAS Pro-30B15D): 10ms-1s | Identical (Same as K240747) |
| Operation Mode: CW, single pulse, repeat pulse | Identical (CW, pulsed, single pulse; Continuous wave, single pulse, pulsed) |
| Operation Interface: Color LCD touch screen | Identical (Color touch screen; Touch screen control; LCD touch screen) |
| Repetition Rate (GBOX-6H, VELAS II-6H): 0.05Hz-50Hz | Similar (Predicate K222701: 0.02-50Hz; Predicate K193656: CW or up to 100Hz) |
| Repetition Rate (GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D): 0.05Hz-50Hz | Similar (Predicate K222701: 0.02-50Hz; Predicate K160952: CW or up to 100Hz) |
| Aiming Beam: Specifications varying by model | Substantially Equivalent |
| Laser Class: 4 | Identical |
| Electrical Safety and EMC: Conformity to IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, IEC 60601-1-6 | Verified. |
| Software Verification and Validation: Conformity to FDA Guidance, "moderate" level of concern. | Documentation provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Animal Study - It is not applicable." and "Clinical Studies - It is not applicable." This indicates that no clinical "test set" (i.e., patient data for direct performance evaluation) was used for this 510(k) submission. The data provenance is therefore not relevant in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical studies or test sets with patient data were conducted for this submission, there were no experts used to establish ground truth for such a test set. The submission relies on establishing equivalence to legally marketed predicate devices, implying their established safety and efficacy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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 laser system, not an AI-powered diagnostic tool, and no MRMC studies were mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies requiring a ground truth for performance evaluation were conducted. The "ground truth" in this context is the safety and efficacy profiles of the predicate devices as legally marketed.
8. The sample size for the training set
Not applicable, as this is a hardware medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a hardware medical device.
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March 19, 2025
Image /page/0/Picture/1 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.
Gigaalaser Company Ltd. Xinxing Nie Regulations Control Manager B15-8F, Wuhan Hi-Tech Medical device park, #818 Gaoxin Road Wu han. 430206 China
Re: K241791
Trade/Device Name: Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) 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 14, 2025 Received: March 14, 2025
Dear Xinxing Nie:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rice"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
YAN FU -S
Digitally signed by YAN FU -S
Date: 2025.03.19 07:21:04
-04'00'
for Tanisha Hithe
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
Medical diode laser systems (GBOX-10D, GBOX-12D, GBOX-15D, GBOX-6H, VELAS Pro-30B15D, VELAS II -6H and VELAS II -15D)
Indications for Use (Describe)
(1) The Medical Diode Laser Systems, model: GBOX-6H, VELAS II-6H is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coaqulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The output wavelength of model GBOX-6H and VELAS II -6H is 1940nm.
(2) The Medical Diode Laser Systems, model: GBOX-10D, GBOX-12D is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endloscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The output wavelength of model GBOX-10D and GBOX-12D is 1470nm.
(3) The Medical Diode Laser Systems, model: GBOX-15D, VELAS II -15D is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The GBOX-15D, VELAS II - 15D is further indicated for laser assisted lipolysis. The output wavelength of model GBOX-15D and VELAS II -15D is 1470nm.
(4) The Medical Diode Laser Systems, model: VELAS Pro-30B15D is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. Medical Diode Laser Systems, model: VELAS Pro-30B15D is further indicated for laser assisted lipolysis. The output wavelength of model VELAS Pro-30B15D is 980nm or 1470nm.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
Prepared on:2025-03-18
I. SUBMITTER
| Device submitter: | Gigaalaser Company Ltd. |
|---|---|
| Add.: | B15-8F, Wuhan Hi-Tech Medical device park, #818 Gaoxin Road, Wuhan430206, China |
| Contact Person: | Name: Xinxing Nie |
| Title: Regulations Control Manager | |
| Phone: +86 18062575326 | |
| Fax: +86-27-6784 8873 | |
| E-mail: fdagigaalaser@sohu.com |
II . DEVICE
| Trade Name of Device: | Medical Diode Laser Systems |
|---|---|
| Model: | GBOX-6H, VELAS II -6H, GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15DVELAS Pro-30B15D |
| Regulation name: | Laser Surgical Instrument for Use in General and Plastic Surgery and inDermatology |
| Classification name: | POWERED LASER SURGICAL INSTRUMENT |
| Classification: | Class II, 21 CFR 878.4810 |
| Primary Product code: | GEX |
| Review Panel: | General & Plastic Surgery |
| 510(k) number: | K241791 |
III. PREDICATE DEVICE
| Predicate Device | |
|---|---|
| Trade name: | MANTA Diode Lasers |
| Classification name: | POWERED LASER SURGICAL INSTRUMENT |
| Regulation number: | 21 CFR 878.4810 |
| Regulation name: | GEX-Powered Laser Surgical Instrument, General and Plastic Surgery |
| Regulatory class: | Class II |
| Product code: | GEX |
| Submitter: | SQUALUS MED Ltd. |
| 510(k) number: | K222701 |
| Predicate Device | |
| Trade name: | SkyPulse Laser Platform |
| Classification name: | POWERED LASER SURGICAL INSTRUMENT |
| Regulation number: | 21 CFR 878.4810 |
| Regulation name: | GEX-Powered Laser Surgical Instrument, General and PlasticSurgery |
| Regulatory class: | Class II |
| Product code: | GEX |
| Submitter: | Fotona d.o.o. |
| 510(k) number: | K193656 |
| Predicate Device | |
| Trade name: | Alma Diode Tabletop Laser |
| Classification name: | POWERED LASER SURGICAL INSTRUMENT |
| Regulation number: | 21 CFR 878.4810 |
| Regulation name: | Laser Surgical Instrument For Use In General And Plastic SurgeryAnd In Dermatology |
| Regulatory class: | Class II |
| Product code: | GEX |
| Submitter: | Alma Ltd |
| 510(k) number: | K160952 |
| Predicate Device | |
| Trade name: | Medical Diode Laser (M2-GK) |
| Classification name: | POWERED LASER SURGICAL INSTRUMENT |
| Regulation number: | 21 CFR 878.4810 |
| Regulation name: | Laser Surgical Instrument For Use In General And Plastic SurgeryAnd In Dermatology |
| Regulatory class: | Class II |
| Product code: | GEX |
| Submitter: | Wuhan Pioon Technology Co.,Ltd. |
| 510(k) number: | K240747 |
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IV. DEVICE DESCRIPTION
(1) The "Medical Diode Laser Systems", include model: GBOX-6H, VELAS II -6H, GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D, VELAS Pro-30B15D which consist of three main components:
(2) Main device;
- (3) Foot switch;
- (3) Accessories.
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 1940nm for GBOX-6H, VELAS II -6H; 1470nm for GBOX-10D, GBOX-12D, GBOX-15D, VELAS III-15D; 980nm or 1470nm for VELAS Pro-30B15D. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.
Image /page/8/Figure/7 description: The image is a block diagram of a laser system. The main components are: Foot switch, Remote Interlock Connector, Power Supply, MCU, LCD, Information Input, Power Calibration, Current Control, Hand piece / Fiber, Laser output, DC-DC Power, Laser Diode, Working Temperature Control, and Temperature Control System. The MCU is connected to the Foot switch, Remote Interlock Connector, LCD, Information Input, and Current Control. The Power Supply is connected to the Remote Interlock Connector, DC-DC Power, and Working Temperature Control. The Current Control is connected to the DC-DC Power. The DC-DC Power is connected to the Laser Diode and Temperature Control System. The Laser Diode is connected to the Hand piece / Fiber and Temperature Control System. The Hand piece / Fiber is connected to the Power Calibration and Laser output. The Power Calibration is connected to the MCU.
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 connector and information input
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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.
V. INDICATIONS FOR USE
(1) The Medical Diode Laser Systems, model: GBOX-6H, VELAS II-6H is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The output wavelength of model GBOX-6H and VELAS II -6H is 1940nm.
(2) The Medical Diode Laser Systems, model: GBOX-12D is indicated for use in surqical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endloscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The output wavelength of model GBOX-10D and GBOX-12D is 1470nm.
(3) The Medical Diode Laser Systems, model: GBOX-15D, VELAS II -15D is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The GBOX-15D, VELAS II -15D is further indicated for laser assisted lipolysis. The output wavelength of model GBOX-15D and VELAS II -15D is 1470nm.
(4) The Medical Diode Laser Systems, model: VELAS Pro-30B15D is indicated for use 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, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. Medical Diode Laser Systems, model: VELAS Pro-30B15D is further indicated for laser assisted lipolysis. The output wavelength of model VELAS Pro-30B15D is 980nm or 1470nm.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Medical Diode Laser System has the same intended use and principal operation, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Medical Diode Laser System and predicate devices do not alter suitability of the proposed device for its intended use.
| Item | Proposed device | Predicate device(K222701) | Predicate device(K193656) | Discussion |
|---|---|---|---|---|
| Medical diode laser systems | MANTA Diode Lasers | SkyPulse Laser Platform | ||
| ProductCode | GEX | GEX | GEX | Identical |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Classification | Class II | Class II | Class II | Identical |
| Indication forUse | Medical Diode Laser Systems, model: GBOX-6H, VELAS II -6H is 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, Thoracic Surgery, Plastic Surgery and Dermatology, | The MANTA1940 diode laser is 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, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, | 1940 nm Diode Laser:- Incision, excision, ablation,- vaporization, hemostasis and/or- coagulation of soft tissue. | Substantial EquivalenceIndication for Use claimed by Proposed device is the same with the Predicate device (K222701).Indication for Use claimed by Proposed device has been |
| General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. | Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. | covered by Predicate device (K193656). | ||
| Laser type | diode laser | diode laser | diode laser | Identical |
| Wavelength | 1940nm | 1940nm | 1940nm | Identical |
| Output power | 1-6W | Up to 5 W | Up to 7.5W | SimilarComment 1 |
| Pulse width | GBOX-6H: 10ms-10sVELAS II -6H: 10ms-10s | 10 msec – 30 sec adjustable | CW or 10ms – 10s | SimilarComment 2 |
| OperationMode | CW, single pulse, repeat pulse | CW, pulsed, single pulse | / | Identical |
| Operationinterface | Color LCD touch screen | Color touch screen | Touch screen control | Identical |
| Repetitionrate | 0.05Hz-50Hz | 0.02-50Hz | CW or up to 100Hz | SimilarComment 3 |
| Aiming beam | Diode laser of 650nm, power ≤3mW,adjustable brightness. Red, Class1M, CW | Red 635-650nm (<5mW) | / | SubstantialEquivalence |
| Laser Class | 4 | 4 | / | Identical |
| Power supply | 100-240 VAC, 50-60Hz, 200VA | 100-240V, 47-63 Hz | / | Substantial |
| Equivalence |
Table 1 Substantial equivalence discussion—GBOX-6H / VELAS II -6H
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Discussion:
Clinical: Indication for Use claimed by Proposed device is the same with the Predicate device (K22701). Indication for Use claimed by Proposed device has been covered by Predicate device (K193656). The indication for use depends on product performance and this difference does not affect safety and effectiveness.
Technology: The subject device has the operation principle and same wavelengths of diode its intended use. The operation mode, Laser Classification, Operation interface are either identical to the main differences are Output power, Pulse width and Repetition rate.
Comment 1 Output power:
The power output range of proposed device is 1-6W, which is similar to the predicate device (K222701): 5W; Also similar to Predicate device (K193656): Up to 7.5 W. By Proposed device has been covered by predicate device (K222701) and (K193656),
Comment 2 Pulse width:
The pulse width of the proposed device: 10ms-10s, somewhat different from the predicate device K222701 (10 msec – 30 sec), is within the scope of what predicate device width of the proposed device: 10ms-10s is the same with the predicate device K193656 (10 ms – 10s).
Comment 3 Pulse Repetition rate:
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Repetition rate of the subject device: 0.05Hz-50Hz is within the scope of what predicate device claims. By Proposed device has been covered by Predicate device (K222701) and (K193656).
Material: The fiber in contact with the subject device has been approved in K140470.
Conclusion:
The subject device has the same intended use and operation principal, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices (K222701) and (K19365). The differences between the subject and predicate devices do not alter suitability of the proposed device for its intended use.
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| Proposed device | Predicate device(K222701) | Predicate device(K160952) | Discussion | |
|---|---|---|---|---|
| Item | Medical diode laser systems | MANTA Diode Lasers | Alma Diode Tabletop Laser | |
| ProductCode | GEX | GEX | GEX | Identical |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Classification | Class II | Class II | Class II | Identical |
| Indication forUse | Medical Diode Laser Systems, model: GBOX-10D/12D is indicatedfor use in surgical applicationsrequiring the vaporization, incision,excision, ablation, cutting andhemostasis, or coagulation of softtissue in conjunction withendoscopic equipment for medicalspecialist including: Urology,Thoracic Surgery, Plastic Surgeryand Dermatology, General Surgery,Ophthalmology, Orthopedics,Podiatry, Arthroscopy, SpinalSurgery, Gynecology, PulmonarySurgery, Neurosurgery,Gastroenterology, Head/neck/ENTand Radiology, Oral Surgery and | The MANTA1470 diode laser isindicated for use in surgicalapplications requiring the vaporization,incision, excision, ablation, cutting andhemostasis, or coagulation of softtissue in conjunction with endoscopicequipment for medical specialistincluding: Urology, Thoracic Surgery,Plastic Surgery and Dermatology,General Surgery, Ophthalmology,Orthopedics, Podiatry, Arthroscopy,Spinal Surgery, Gynecology,Pulmonary Surgery, Neurosurgery,Gastroenterology, Head/neck/ENT andRadiology, Oral Surgery and Dentalprocedures. | The Alma 1470 nm diode tabletoplaser is indicated for use inendovenous occlusion of the greatersaphenous vein in patients withsuperficial vein reflux. The Alma1470 nm diode tabletop laser isfurther indicated for laser assistedlipolysis. | SubstantialEquivalenceIndication for Useclaimed by Proposeddevice has beencovered by Predicatedevice (K222701)and (K160952).Indication for Useclaimed by Proposeddevice Medical DiodeLaser Systems,model: GBOX-10D/12D is the samewith the Predicatedevice (K222701).Indication for Use |
| Dental procedures.Medical Diode Laser Systems,model: GBOX-15D, VELAS II -15D isindicated for use in endovenousocclusion of the greater saphenousvein in patients with superficial veinreflux. The GBOX-15D, VELAS II -15D is further indicated for laserassisted lipolysis. | claimed by Proposeddevice Medical DiodeLaser Systems,model: GBOX-15D,VELAS II -15D is thesame with thePredicate device(K160952). | |||
| Laser type | diode laser | diode laser | diode laser | Identical |
| Wavelength | 1470nm | 1470nm | 1470nm | Identical |
| Output power | GBOX-10D: 1-10WGBOX-12D: 1-12WGBOX-15D: 1-15W | Up to 12 W | Up to 15 W | SimilarComment 1 |
| Pulse width | 10ms-10s | 10 msec - 30 sec adjustable | 10-990ms | SimilarComment 2 |
| OperationMode | CW, single pulse, repeat pulse | CW, pulsed, single pulse | Continuous wave, single pulse,pulsed | Identical |
| Operationinterface | Color LCD touch screen | Color touch screen | LCD touch screen | Identical |
| Repetitionrate | 0.05Hz-50Hz | 0.02-50Hz | CW or up to 100Hz | SimilarComment 3 |
| Aiming beam | GBOX-10D/12D/15D: Diode laser of650nm, power ≤3mW, adjustablebrightness. Red, Class 1M, CW; | Red 635-650nm (<5mW) | 635nm | SubstantialEquivalence |
| VELAS II -15D: Diode laser of 650nm, power ≤2mW, adjustable brightness. | ||||
| Laser Class | 4 | 4 | / | Identical |
| Power supply | 100-240 VAC, 50-60Hz, 200VA | 100-240V, 47-63 Hz | / | SubstantialEquivalence |
Table 2 Substantial equivalence discussion—GBOX-10D / GBOX-12D / GBOX-15D / VELAS II -15D
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Discussion:
Clinical: Indication for Use claimed by Proposed device Medical Diode Laser Systems, model: GBOX - 10D/12D is the same with the Predicate device (K222701). Indication for Use claimed by Proposed device Medical Diode Laser Systems, model: GBOX-15D, VELAS II -15D is the same with the Predicate device (K160952).
Indication for Use claimed by Proposed device has been covered by Predicate device(K222701) and (K16095) which depends on product performance, and this difference does not affect safety and effectiveness.
Technology: The subject device has the same wavelengths of diode laser to achieve its intended use. The operation mode, Laser Classification, Operation interface are either identical to the main differences are Output power, Pulse width and Repetition rate.
Comment 1 Output power:
The Proposed device Medical Diode Laser Systems, model: GBOX-10D/12D has a power output range of 1-10W/1-12W, which is with the scope of what Predicate device (K222701): Max. 12W claims.
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The Proposed device Medical Diode Laser Systems, model: GBOX-15D, VELAS II -15D has a power output range of 1-15W, which is with the scope of what Predicate device (K160952): Max. 15W claims.
Comment 3 Pulse width:
The pulse width of the subject device: 10ms~10s, somewhat different from the Predicate device (K160952), but within the scope of what Predicate device (K222701) claims.
Comment 3 Repetition rate:
Repetition rate of the subject device: 0.05Hz-50Hz is within the scope of what Predicate device claims. By Proposed device has been covered by Predicate device (K222701) and (K160952).
Material: The fiber in contact with the subject device has been approved in K140470.
Conclusion:
The subject device has the same intended use and operation principle, the technology, design and performance specifications are either idenical or substantially equivalent to existing legally market predicate devices (K222701) and (K160952). The differences between the subject and predicate devices do not alter suitability of the proposed device for its intended use.
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| Item | Proposed device | Predicate device(K240747) | Discussion |
|---|---|---|---|
| Medical diode laser systems | Medical Diode Laser (M2-GK) | ||
| ProductCode | GEX | GEX | Identical |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Classification | Class II | Class II | Identical |
| Indication forUse | Medical Diode Laser Systems, model: VELASPro-30B15D is indicated for use in surgicalapplications requiring the vaporization,incision, excision, ablation, cutting andhemostasis, or coagulation of soft tissue inconjunction with endoscopic equipment formedical specialist including: Urology,Thoracic Surgery, Plastic Surgery andDermatology, General Surgery,Ophthalmology, Orthopedics, Podiatry,Arthroscopy, Spinal Surgery, Gynecology,Pulmonary Surgery, Neurosurgery,Gastroenterology, Head/neck/ENT andRadiology, Oral Surgery and Dentalprocedures, Endovascular coagulation andendovenous occlusion of the greatersaphenous vein in patients with superficialvein reflux. Medical Diode Laser Systems, | The Medical Diode Laser (Model: M2-GK) isindicated for use in surgical applicationsrequiring the vaporization, incision, excision,ablation, cutting and hemostasis, orcoagulation of soft tissue in conjunction withendoscopic equipment for medical specialistincluding: Urology, Thoracic Surgery, PlasticSurgery and Dermatology, General Surgery,Ophthalmology, Orthopedics, Podiatry,Arthroscopy, Spinal Surgery, Gynecology,Pulmonary Surgery, Neurosurgery,Gastroenterology, Head/neck/ENT andRadiology, Oral Surgery and Dentalprocedures, Endovascular coagulation andendovenous occlusion of the greatersaphenous vein in patients with superficialvein reflux. The Medical Diode Laser (Model:M2-GK) is further indicated for laser assisted | Identical |
| model: VELAS Pro-30B15D is further indicated for laser assisted lipolysis. | lipolysis. | ||
| Laser type | diode laser | diode laser | Identical |
| Wavelength | 980nm; 1470nm | 980nm; 1470nm | Identical |
| Max Output power | 980nm: 30W1470nm: 15W | 980nm: 30W1470nm: 15W | Identical |
| Pulse width | 10ms-1s | 10ms-1s | Identical |
| Operation Mode | CW, single, repeat | CW, single pulse, repeat pulse | Identical |
| Aiming beam | Diode laser of 635nm power<5mW, and520nm, power< 3.5mW; adjustablebrightness. | Red 650nm (<2mW) | Substantial Equivalence |
| Cooling | Air | Air | Identical |
| Laser Class | 4 | 4 | Identical |
| Power supply | 100-240 VAC, 50-60Hz, 200VA | 100-240VAC, 50/60Hz,4A-2A | Substantial Equivalence |
Table 3 Substantial equivalence discussion—VELAS Pro-30B15D
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Discussion:
Technology: The subject device has the same operation principle and same wavelengths of diode use.
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The operation mode, Laser Classification, Operation interface and main core technical specifications are either identical to the predicate.
Material: The fiber in contact with the subject device has been approved in K140470.
Conclusion:
The subject device has the same intended use and operation principle, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices (K240747). There are no differences between the subject and predicate devices.
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Medical Diode Laser Systems.
- Verify the conformity of the proposed devices with the requirements of 2005(R)2012 IEC60601-1 :( Medical electrical equipment Part 1: General requirements for basic safety and essential performance).
- Verify the conformity of the proposed devices with the requirements of 2020-09 IEC60601-1-2 :( Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic compatibility).
- Verify the conformity of the proposed devices to 2007-03 IEC 60825-1 (Safety of laser products - Part 1: Equipment classification and requirements).
- Verify the performance of the proposed devices according to 2012-10 IEC 60601-2-22: (Medical electrical equipment Part 2: Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment).
- Verify the conformity of the proposed devices with the requirements of 2020-07 IEC 60601-1-6:(Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability)
Software Verification and Validation Testing
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." The software for this device was considered as a "moderate" level of concern.
Mechanical and acoustic testing
It is not applicable.
Animal Study
It is not applicable.
Clinical Studies
It is not applicable.
VIII. CONCLUSIONS
The Medical Diode Laser Systems is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed devices.
§ 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.