980nm Diode Laser Therapy Device

K191349 · Shanghai Apolo Medical Technology Co., Ltd. · GEX · Aug 16, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K191349
• Device Name: 980nm Diode Laser Therapy Device
• Applicant: Shanghai Apolo Medical Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 16, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization, incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as: vascular lesions and dental procedure.

Device Story

Desktop 980nm semiconductor diode laser system; delivers laser energy via fiber optic delivery system to soft tissue. Components include power supply, control system, cooling system, and laser source. Operated by clinician via color LCD touch screen and footswitch. Aiming beam (650nm) assists targeting. Device performs vaporization, incision, excision, ablation, cutting, and hemostasis/coagulation. Benefits include precise soft tissue management in surgical, dermatological, and dental contexts.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and laser safety (IEC 60825-1, IEC 60601-2-22).

Technological Characteristics

GaA1As semiconductor diode laser; 980nm wavelength; 1-30W output power. Fiber delivery system (300µm core, NA=0.22, SMA905). 650nm aiming beam. Color LCD touch screen interface. Powered by 100-240VAC. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22.

Indications for Use

Indicated for surgical applications requiring vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue, specifically including vascular lesions and dental procedures.

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 Systems (K151890)

Submission Summary (Full Text)

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August 16, 2019

Shanghai Apolo Medical Technology Co., Ltd. % Claire Zhang Manager Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705 , Building 1, West Guangzhong Road 555, Jingan District, Shanghai, 200071 China

Re: K191349

Trade/Device Name: 980nm Diode Laser Therapy Device 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: May 17, 2019 Received: May 20, 2019

Dear Claire Zhang:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-emitting products, including information about labeling regulations, please see Device (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-regulatoryassistance/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,

Neil R. P. Ogden, M.S. Acting Team Assistant Director Light Based Devices Team 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K191349

Device Name Diode Laser Therapy Device

Indications for Use (Describe)

HS-890A 980mm Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization , incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as vascular lesions and dental procedure.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Section 3-510(k) summary

## I Submitter

Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District, Shanghai 200231,China

Establishment Registration Number: 3007120647

Contact person: Felix Li Position: Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: [e-mail]

# II Proposed Device

| Trade Name of Device: | 980nm Diode Laser Therapy Device |
|-----------------------|-----------------------------------|
| Common name: | Powered Laser Surgical Instrument |
| Regulation Number: | 21 CFR 878.4810 |
| Regulatory Class: | Class II |
| Product code: | GEX |
| Review Panel: | General & Plastic Surgery |

### III Predicate Devices

| 510(k) Number: | K151890 |
|-----------------|-------------------------------------------------|
| Trade name: | Medical Diode Laser Systems |
| Common name: | Powered Laser Surgical Instrument |
| Classification: | Class II |
| Product Code: | GEX |
| Manufacturer | Wuhan Gigaa Optronics Technology Company., Ltd. |

### IV Device description

The Diode Laser Therapy Device is a desktop device which utilizes a semiconductor diode with invisible infrared radiation as a laser source (980nm). The laser power is delivered to the treatment via a delivery system.

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The proposed device includes power supply system, delivery system, control system, cooling system and laser system.

#### V Indication for use

The Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization, incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as: vascular lesions and dental procedure.

| Item | Proposed device | Predicate device<br>(K151890) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Diode Laser Therapy Device | Medical Diode Laser System |
| Product Code | GEX | GEX |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class | Class II | Class II |
| Model | HS-890A | VELAS II-30B |
| Indication for use | The Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization, incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as: vascular lesions and dental procedure. | The “VELAS II-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<br>Surgery and Dental Procedures,<br>Lase assisted lipolysis. |
| Laser Type | GaA1As Diode Laser | GaA1As Diode Laser |
| Components | Laser system, Color touch<br>screen, Fiber, Footswitch | Laser system, Color touch screen,<br>Fiber, Footswitch. |
| Wavelength | 980nm±10nm | VELAS II-30B: 980nm±10nm |
| Output<br>power | 1-30W | 1-30W |
| Pulse width | 5~400ms | 10ms~2.5s |
| Operation<br>mode | CW, single pulse, repeat<br>pulse | CW, single pulse, repeat pulse |
| Light<br>Delivery<br>system | Fiber core diameter: 300µm,<br>NA=0.22<br>With SMA905 connector | Fiber core diameter: 400µm, 600µm<br>NA≥0.22<br>With SMA905 connector |
| Aiming<br>beam | 650nm, ≤2mW , adjustable | Diode laser of 635/532nm power<br>max.<5mW, adjustable. |
| Laser class | 4 | 4 |
| Operation<br>interface | Color LCD touch screen | Color LCD touch screen |
| Power<br>supply | 100-240VAC, 50/60Hz | 100-240VAC, 50/60Hz, |
| Dimension | 280mm[W]× 270mm[L]×<br>370mm[H] | 400mm[W]×385mm[L]×200mm[H] |
| Weight | 8kg | 12.9kg |
| Safety<br>classification | Class I | Class I |
| Software | Yes | Yes |

#### VI Comparison of technological characteristics with the predicate devices

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## VII Non-Clinical Testing

A battery of tests have been performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:

### Electrical safety and electromagnetic compatibility

IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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IEC 60601-1-2:2014 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

IEC 60601-2-22:2007(third edition) +A1:2012 for use in conjunction with IEC 60601-1:2005 (third edition) +A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

### VIII Clinical Testing

It is not applicable.

### IX Conclusion

Base on the performance testing and validation studies that the subject device is substantially equivalent to the predicate device.