(166 days)
Not Found
No
The device description focuses on the hardware components and basic operation of a diode laser system. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for analysis, decision-making, or automated control beyond basic parameter settings.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices (GBOX-15A/15B, VELASII-30A/30B, VELASII -60A/60B/60C) are indicated for various surgical applications including vaporization, incision, excision, ablation, cutting, hemostasis, and coagulation of soft tissue, which are all therapeutic actions. Additionally, the "Summary of Performance Studies" mentions "surgical, cosmetic, therapeutic and diagnostic laser equipment".
No
The "Intended Use / Indications for Use" section specifies the device is for surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue, which are all treatment-oriented functions, not diagnostic ones.
No
The device description clearly states it is a "Medical diode laser system" which is a hardware device consisting of working material, cavity resonator, and power source. While it mentions software verification, the core device is a physical laser system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are for surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue. These are all procedures performed on the body, not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a medical diode laser system used for surgical procedures. It describes the laser's components and how it is used to emit a laser beam for treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies listed are related to the safety and performance of the laser system itself in a surgical context (electrical safety, biological evaluation of materials, software verification), not to the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely therapeutic/surgical.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, greater saphenous vein of the thigh (for Endovenous Occlusion)
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)
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.
Key results for GBOX-15A/15B: 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.
Key results for VELAS II-30A/30B, VELAS II-60A/60B/60C: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
1
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
2
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)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
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
5
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 Optronics | ||
| Technology Co., Ltd. | PhotoMedex, Inc. | ------- | |
| Indications for use | The Medical Diode Laser Systems “GBOX-15A/15B” | ||
| are indicated for use in surgical applications requiring the | |||
| ablation, 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 Assisted | |||
| Lipolysis (980 nm only). | The PhotoMedex LaserPro 810, 940 and 980 Surgical | ||
| Diode Laser Systems, (and the fiber delivery systems | |||
| and accessories used to deliver laser energy), are | |||
| indicated for use in surgical applications requiring the | |||
| ablation, 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 Assisted Lipolysis (980 nm | |||
| only). | 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 GBOX | |||
| only uses fiber as the laser transmission | |||
| system does not affect the safety and | |||
| effectiveness. | |||
| Wavelength | GBOX-15A: 810nm±10nm | ||
| GBOX-15B: 980nm±10nm | LaserPro 810: 810nm±10% | ||
| LaserPro 980: 980nm±10% | Similar. | ||
| Center wavelength is | |||
| consistent, and GBOX | |||
| wavelength accuracy is | |||
| better than that of the | |||
| predicate device. | |||
| Output power | 1-15W | 1-15W | |
| 1-20W | |||
| 1-25W | Similar. | ||
| Same as 1-15W. GBOX | |||
| design output power | |||
| has claimed to meet | |||
| intended 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 of | |||
| the device is contained | |||
| in that of the predicate | |||
| device, and it has been | |||
| designed to meet the | |||
| intended use | |||
| requirement claimed. | |||
| Application / Light | |||
| delivery system | Bare fiber, long as 3m | ||
| Fiber core diameter: 400µm, | |||
| 600μm | |||
| NA $\ge$ 0.22 | |||
| With SMA905 connector | |||
| The fiber is use on a single | |||
| patient for once | |||
| Before use must sterile | |||
| contact: fibers of 400μm, 600μm | |||
| with SMA905 connector; | |||
| Non-contact: fibers and tips | SMA905 connector | ||
| Silica fiber core diameters | |||
| greater than or equal to 365 | |||
| microns and Fiber numerical | |||
| aperture greater than or equal to | |||
| 0.29 NA | Similar. | ||
| Aiming Beam | Diode laser of 635nm, power | ||
| max. $ |