SurgiLight 1470 Diode Laser System (Model:Halo)

K251049 · Micro-Energy Medical Technology Co., Ltd. · GEX · Jul 2, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K251049
• Device Name: SurgiLight 1470 Diode Laser System (Model:Halo)
• Applicant: Micro-Energy Medical Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 2, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

SurgiLight 1470 Diode Laser System (Model: Halo) uses 1470nm Gallium Arsenide (GaAs) diode laser for soft tissue surgery; includes 650nm red aiming beam. System comprises main unit, footswitch, power cord, and remote interlock. User operates via LCD touchscreen to set output parameters. Laser energy delivered via optical fibers with SMA905 connectors. Used in clinical/surgical settings by medical specialists for diverse procedures including urology, dermatology, and endovenous occlusion. Device provides precise tissue interaction (vaporization/coagulation) to facilitate surgical outcomes. Includes internal lithium battery for portable operation.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and software verification/validation.

Technological Characteristics

1470nm GaAs diode laser; 650nm red aiming beam. Output power 12W. Modes: CW, single-pulse, repeat-pulse. Fiber delivery via SMA905. Power: 100-240V AC or internal 14.8V 12,800mAh Li-ion battery. LCD touchscreen interface. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.

Indications for Use

Indicated for adult patients requiring soft tissue surgical procedures including vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation in various medical specialties, including endovenous occlusion for superficial vein reflux.

Regulatory Classification

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.

Predicate Devices

• Medical Diode Laser (K240644)
• neoV980&neoV1470 Diode Lasers (K152722)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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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
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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 ([e-mail]) or phone [phone] 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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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. | |
| 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.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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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.: [phone]
Fax No.: [phone]
Email Address.: [e-mail]
Submission Number: K251049

2. Correspondent's Information

Company Name: Micro-Energy Medical Technology Co., Ltd.
Correspondent Name: Danning Zhu
Telephone No.: [phone]
Email Address: [e-mail]

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 Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, | 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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| | | 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. | |
| --- | --- | --- | --- | --- | --- |
| Targer 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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| 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),Single-Pulse 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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| 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 |
| Microprocess or 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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7

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 needed 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.