(90 days)
The SurgiLight 1470 Diode Laser System (Model: Halo) 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, 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.
The SurgiLight 1470 Diode Laser System (model: Halo) incorporates a 1470nm wavelength Gallium Arsenide (GaAs) diode laser for producing its therapeutic effects. The device also incorporates a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, footswitch, a power cord and remote interlock components. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device. The device transmits the laser output via optical fibers with SMA905 connectors.
This document is a 510(k) clearance letter for the SurgiLight 1470 Diode Laser System (Model:Halo). It states that the device is substantially equivalent to legally marketed predicate devices.
Important Note: The provided document is a 510(k) clearance letter for a laser surgical instrument. These types of devices typically demonstrate substantial equivalence through performance testing against recognized consensus standards and comparison of technological characteristics to predicate devices. They do not involve AI-based image analysis or diagnostic capabilities that would require the kind of complex study design (e.g., MRMC studies, human reader improvement metrics, expert consensus ground truth for image data) described in your request.
Therefore, many of the specific criteria related to AI performance studies (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to this type of medical device clearance.
Here's an analysis based on the information provided in the 510(k) document, addressing your questions where applicable and noting when information is not pertinent to this device type:
Acceptance Criteria and Device Performance for SurgiLight 1470 Diode Laser System (Model:Halo)
Based on the 510(k) summary, the "acceptance criteria" are primarily demonstrated through compliance with recognized international standards for medical electrical equipment and a comparison of technical specifications to legally marketed predicate devices. The "study" proving the device meets these criteria is the non-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the compliance with the listed standards and the demonstrated substantial equivalence to predicate devices in key technical specifications.
| Acceptance Criteria (Implied by Standards & Predicate Comparison) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Safety and Essential Performance (General) | Compliance with IEC 60601-1:2005/A2:2021 (General requirements for basic safety and essential performance). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014+A1:2020 (Electromagnetic disturbances - Requirements and tests). |
| Laser Specific Safety and Performance | Compliance with IEC 60601-2-22:2019 (Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment). |
| Laser Product Safety Classification | Compliance with IEC 60825-1:2014 (Safety of laser products - Part 1: Equipment classification and requirements). Device is Level 4 Laser. |
| Intended Use/Indications for Use Equivalence | Same as predicate devices (K240644, K152722): surgical applications requiring vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for various medical specialties (Urology, Thoracic, Plastic/Dermatology, General, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal, Gynecology, Pulmonary, Neurosurgery, Gastroenterology, Head/neck/ENT, Radiology, Oral/Dental, Endovascular coagulation, and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux). Target population: Adult. |
| Technological Characteristics Equivalence | Product Code: GEX (Same) Regulation No.: 21 CFR 878.4810 (Same) Class: II (Same) Laser Type: Diode laser (Same) Wavelength: 1470nm (Same) Working Mode: CW, Single Pulse, Repeat Pulse (Same) Laser Beam Transmission Mode: fiber (Same) Laser Level: Level 4 (Same) Operation Interface: Color LCD touch screen (Same) Microprocessor Control: Yes (Same) Therapeutic Maximum Laser Output Power: 12 W (Same as K240644, Similar to K152722 – 10 W). This is acceptable as new device is within safe and effective range. Pulse Width: 5 ms - 9,000 ms (Similar to K240644 (10ms-25s), within scope of K152722 (100μs-30s)). Repetition Rate: 0.06HZ-100HZ (Similar to K240644 (0-50HZ), within scope of K152722 (0.02 Hz to 5,000 Hz)). Aiming Beam Technical Features: Visible red laser Power:<2.6mW, Wavelength:650nm, adjustable brightness (Similar to predicates which have visible red aiming beams, differing slightly in specific power/wavelength but functionally equivalent for aiming). Power Supply: AC power (100-240V~ 50/60 Hz; 6.5A Max) and Internal lithium battery (14.8 V, 12,800 mAh, rechargeable) (Similar to predicates, differences don't affect safety/effectiveness). |
2. Sample Size Used for the Test Set and the Data Provenance
- Not Applicable in the traditional sense of a clinical or image-based test set. For a laser surgical instrument, "testing" refers to bench testing and compliance with electrical, safety, and performance standards. There is no "test set" of patient data or images.
- The data provenance would be from internal laboratory testing conducted by Micro-Energy Medical Technology Co., Ltd. for product verification and validation. It is retrospective in the sense that the results are used to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This device does not use AI or diagnostic imaging where expert-established ground truth on a test set of clinical images would be necessary. Performance is evaluated against engineering specifications and industry standards.
4. Adjudication Method for the Test Set
- Not Applicable. There is no "test set" of clinical cases requiring adjudication by human experts.
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
- No, an MRMC comparative effectiveness study was not done. This is a laser surgical instrument, not an AI-assisted diagnostic imaging device. Therefore, the concept of human reader improvement with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device (laser system), not a standalone AI algorithm.
7. The type of ground truth used
- For this device, the "ground truth" is defined by:
- Engineering Specifications: The device's output power, wavelength, pulse parameters, etc., must meet its design specifications.
- Consensus Standards: Compliance with the requirements outlined in IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1 serves as the ground truth for safety and essential performance.
- Predicate Device Characteristics: The functional and technological characteristics are compared to those of legally marketed predicate devices to establish substantial equivalence.
8. The sample size for the training set
- Not Applicable. This device does not involve machine learning algorithms requiring a training set of data.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
In summary, the provided 510(k) clearance describes a laser surgical device, not an AI-powered diagnostic tool. The acceptance criteria and supporting studies focus on demonstrating device safety, performance, and substantial equivalence to existing devices through compliance with recognized standards and technical characteristic comparisons, rather than clinical efficacy studies involving patient data or AI algorithm validation.
FDA 510(k) Clearance Letter - SurgiLight 1470 Diode Laser System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
July 2, 2025
Micro-Energy Medical Technology Co., Ltd
Danning Zhu
Registered Engineer
Section B4301, B4701 and B4901, No. 13, Baolan Road
Kengzi Street, Pingshan District
Shenzhen, Guangdong 518118
China
Re: K251049
Trade/Device Name: SurgiLight 1470 Diode Laser System (Model:Halo)
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: April 3, 2025
Received: April 3, 2025
Dear Danning Zhu:
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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K251049 - Danning Zhu Page 2
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 820.30 and 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 (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-reporting-combination-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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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.
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K251049 - Danning Zhu Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.07.02 19:36:22 -04'00'
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251049
Device Name: SurgiLight 1470 Diode Laser System (ModelHalo)
Indications for Use (Describe):
The SurgiLight 1470 Diode Laser System (Model: Halo) 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, 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.
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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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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510(k) Summary
Date Prepared: July 2nd, 2025
This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1. Submitter's Information
Name of Sponsor: Micro-Energy Medical Technology Co., Ltd.
Address: Section B4301, B4701 and B4901 No.13, Baolan Road, Kengzi Street, Pingshan District, Shenzhen, China
Contact Name: Elly Xu
Telephone No.: +8613823755713
Fax No.: +8613823755713
Email Address: sha.x@micro-energy.com
Submission Number: K251049
2. Correspondent's Information
Company Name: Micro-Energy Medical Technology Co., Ltd.
Correspondent Name: Danning Zhu
Telephone No.: +8613580568872
Email Address: danning.z@micro-energy.com
3. Trade Name, Common Name, Classification
| Trade Name: | SurgiLight 1470 Diode Laser System |
|---|---|
| Common Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Model: | Halo |
| Classification Name: | Powered Laser Surgical Instrument |
| Product Code: | GEX |
| Classification Panel: | General & Plastic Surgery |
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| Device Class: | II |
|---|---|
| Classification Regulation: | 21 CFR 878.4810 |
4. Identification of Predicate Device(s)
The identified predicates within this submission are as follows:
| Predicate Device 1: | 510(k) number: K240644 |
|---|---|
| Trade name: Medical Diode Laser | |
| Product code: GEX | |
| Predicate Device 2: | 510(k) number:K152722 |
| Trade name:neoV980&neoV1470 Diode Lasers | |
| Product code: GEX |
5. Description of the Device
The SurgiLight 1470 Diode Laser System (model: Halo) incorporates a 1470nm wavelength Gallium Arsenide (GaAs) diode laser for producing its therapeutic effects. The device also incorporates a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, footswitch, a power cord and remote interlock components. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device. The device transmits the laser output via optical fibers with SMA905 connectors.
6. Intended Use/Indication for Use
The SurgiLight 1470 Diode Laser System (Model: Halo) 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, 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.
7. Technological Characteristics
The SurgiLight 1470 Diode Laser System (model:Halo) uses the same technology that is utilized in the predicate device. A comparison of technological characteristics is provided in the following table:
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| Item | Subject device (K251049) | Predicate device (K240644) | Predicate device (K152722) | Comparison |
|---|---|---|---|---|
| Product Code | GEX | GEX | GEX | Same |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Class | II | II | II | Same |
| Device Name | SurgiLight 1470 Diode Laser System | Medical Diode Laser | neoV980&neoV1470 Diode Lasers | NA |
| Device Model | Halo | S1 Pro | neoV980&neoV1470 Diode Lasers | NA(Only compare the parameters at a wavelength of 1470) |
| Manufacturer | Micro-Energy Medical Technology Co., Ltd. | Wuhan Pioon Technology Co.,Ltd. | G.N.S NEO LASER LTD. | NA |
| Intended Use/Indication for Use | The SurgiLight 1470 Diode Laser System (Model: Halo) 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 | The Medical Diode Laser(Model:S1Pro)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, Spinal Surgery, | The neoV980 & neoV1470 Diode Lasers, (and their delivery accessories used to deliver optical energy) 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 specialties | Same |
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| Item | Subject device (K251049) | Predicate device (K240644) | Predicate device (K152722) | Comparison |
|---|---|---|---|---|
| Intended Use/Indication for Use (continued) | 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. | 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. The Medical Diode Laser (Model: S1Pro) is further indicated for laser assisted lipolysis. | 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 greatest saphenous vein in patients with superficial vein reflux. | Same |
| Target Population | Adult | Adult | Adult | Same |
| Laser Type | Diode laser | Diode laser | Diode laser | Same |
| Therapeutic Maximum Laser Output Power | 12 W | 12w | 10 W | Same as the predicate device(K240644), Similar with the predicate device(K152722) |
| Wave Length | 1470nm | 1470nm | 1470nm | Same |
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| Item | Subject device (K251049) | Predicate device (K240644) | Predicate device (K152722) | Comparison |
|---|---|---|---|---|
| Laser Technical Features | ||||
| Pulse Width | 5 ms - 9,000 ms | 10ms-25s | 100μs-30s | Similar with the predicate device(K240644), within the scope of predicate device(K152722) Note01 |
| Repetition Rate | 0.06HZ-100HZ | 0-50HZ | 0.02 Hz to 5,000 Hz | Similar with the predicate device(K240644), within the scope of predicate device(K152722) Note02 |
| Working Mode | Continuous Wave (CW),SinglePulse and repeated plus | CW, single pulse, repeat pulse | CW, single pulse, repeat pulse | Same |
| Laser Beam Transmission Mode | fiber | fiber | fiber | Same |
| Laser Level | Level 4 | Level 4 | Level 4 | Same |
| Aiming Beam (light)Technical Features | Visible red laser Power:<2.6mW Wave Length:650nm adjustable brightness. | Visible red laser Power:＜2mW Wave Length:650nm adjustable brightness. | Green 532nm (<5mW) | Similar Note03 |
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| Item | Subject device (K251049) | Predicate device (K240644) | Predicate device (K152722) | Comparison |
|---|---|---|---|---|
| Operation interface | Color LCD touch screen | Color LCD touch screen | Color LCD touch screen | Same |
| Power Supply | AC power: 100 - 240 V~ 50/60 Hz; 6.5A Max Internal lithium battery: 14.8 V, 12,800 mAh; rechargeable; it can support the maximum power output of the product for at least 30 min when it is fully charged. | 100-240V AC,50/60Hz 2.5A Max | 100 - 240 VAC, 47/63Hz, 1.06-0.45A | Similar Note04 |
| Microprocessor Control | Yes | Yes | Yes | Same |
| Standard | IEC60601-1 IEC60601-1-2 IEC60601-2-22 IEC60825-1 | IEC60601-1 IEC60601-1-2 IEC60601-2-22 IEC60825-1 | IEC60601-1 IEC60601-1-2 IEC60601-2-22 IEC60825-1 | Same |
As seen in the comparison tables,the subject device uses similar 1470nm diode laser technology as that used by the predicates.The subject device has the same classification information, same indications and intended use, same design principle, same therapeutic laser technical features similar aiming beam (light) technical features and power supply.The minor differences only exist in the technical features of the aiming beam (light) and the power supply. Moreover, both the subject devices and the predicate devices meet the same standards, namely IEC60601-1, IEC60601-1-2, IEC60601-2-22 and IEC60825-1.The differences between the subject device and predicate devices do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
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8. Discussion of Non-clinical Testing
To verify the performance requirements of SurgiLight 1470 Diode Laser System (model:Halo) the following tests were performed. It shows that the testing results do support substantial equivalence.
IEC 60601-2-22:2019
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60601-1-2:2014+A1:2020
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IEC 60825-1：2014
Safety of laser products -Part 1:Equipment classification and requirements
ANSI/AAMIES60601-1:2005/A2:2021
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance .
9. 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, "Content of Premarket Submissions for Device Software Function". The recommended Documentation Level for software of this device was considered as a "Basic Documentation Level " and the documentation was provided accordingly.
10. Brief discussion of clinical tests
No human clinical data is need for SurgiLight 1470 Diode Laser System (model:Halo) .
11. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Micro-Energy Medical Technology Co., Ltd concludes that:
- The indications for use of SurgiLight 1470 Diode Laser System (model:Halo) are the same as those of the predicate devices.
- The technological characteristics are the same or similar to those of the predicate devices.
- Demonstrated by the safety and performance tests, SurgiLight 1470 Diode Laser System (model:Halo) is substantially equivalent to the predicate 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.