Dental diode laser, SOGA Laser, ILaser II

K211150 · Shenzhen Soga Technology Co., Ltd. · NVK · Jul 1, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K211150
• Device Name: Dental diode laser, SOGA Laser, ILaser II
• Applicant: Shenzhen Soga Technology Co., Ltd.
• Product Code: NVK · General, Plastic Surgery
• Decision Date: Jul 1, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakcia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty Tissue retraction for impression Laser Periodontal Procedures, including: Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility).

Device Story

Dental diode laser (ILaser II) used by dental surgeons in hospitals, clinics, and medical offices. Device consists of a laser host (power supply, drive system, optical path, LCD screen) and an optical fiber tip. Semiconductor laser diode generates laser energy transmitted via fiber optic tip to the treatment site. Used for soft tissue procedures (biopsies, frenectomy, gingivectomy, periodontal debridement). Provides precise tissue interaction for incision, excision, vaporization, ablation, and coagulation. Benefits include improved clinical indices in periodontal pockets and efficient soft tissue management. Clinician operates device via control interface; output is laser energy delivered to target tissue.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60825-1 and IEC 60601-2-22 (laser performance/safety), and ISO 10993-5/10 (biocompatibility).

Technological Characteristics

Class IV semiconductor diode laser; 980nm ±20nm wavelength; 3.0W max CW / 5.0W peak power. Enclosure: 316L stainless steel; Cover: silica gel. Fiber optic delivery. Connectivity: standalone. Sterilization: fiber optic tip and handpiece cover require sterilization. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for all patients requiring incision, excision, vaporization, ablation, and coagulation of oral soft tissues, including periodontal procedures and treatment of oral mucosal ulcers.

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

• iLase (K093852)

Submission Summary (Full Text)

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July 1, 2022

Shenzhen Soga Technology Co., Ltd. Tse Adrian Quality Manager D906, Yinxing Technology Building No. 1301, Sightseeing Road, Xinlan Community, Guanlan Street Shenzhen, Guandong 518110 CHINA

Re: K211150

Trade/Device Name: Dental diode laser, SOGA Laser, ILaser II 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: NVK Dated: June 21, 2022 Received: June 21, 2022

Dear Tse Adrian:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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.

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K211150

#### Device Name

Dental Diode Laser, SOGA Laser, ILaser II

| Indications for Use ( <i>Describe</i> ) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dental Soft Tissue Indications: |
| Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: |
| Excisional and incisional biopsies |
| Exposure of unerupted teeth |
| Fibroma removal |
| Frenectomy |
| Frenotomy |
| Gingival troughing for crown impressions |
| Gingivectomy |
| Gingivoplasty |
| Gingival incision and excision |
| Hemostasis and coagulation |
| Implant recovery |
| Incision and drainage of abscess |
| Leukoplakcia |
| Operculectomy |
| Oral papillectomies |
| Pulpotomy |
| Pulpotomy as an adjunct to root canal therapy |
| Reduction of gingival hypertrophy |
| Soft tissue crown lengthening |
| Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. |
| Vestibuloplasty |
| Tissue retraction for impression |
| |
| Laser Periodontal Procedures, including: |
| Laser soft tissue curettage |
| Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket |
| Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility). |
| |
| Type of Use ( <i>Select one or both, as applicable</i> ) |
| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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Image /page/4/Picture/1 description: The image shows the logo for SOGA. The logo is in a dark gray color, except for a small portion of the letter A, which is in green. Below the logo, there are some Chinese characters.

#### 005 510(k) Summary K211150

#### 5.1 Submitter Information

- Company: Shenzhen Soga technology Co., Ltd.
- Address: D906, Yinxing Technology Building No. 1301, Sightseeing Road, Xinlan Community, Guanlan Street, Longhua District, Shenzhen, Guangdong, China.
- Phone: [phone] ●
- Contact: Tse Adrian, Quality Manager
- Mail box: [e-mail] ●
- Website: www.soga12.com

#### 5.2 Device Information

- Trade/Device Name: Dental diode laser, SOGALaser ●
- Model: ILaser II
- Common Name: Dental diode laser
- Classification requlation: Regulation number: 21 CFR 878.4810 Regulation Description: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulation Medical Specialty: General & Plastic Surgery
- Review Panel: General & Plastic Surgery ●
- Product Code: GEX
- Regulation Number: 21 CFR 878.4810
- Device Class: Class II
- Submission number: K211150

#### 5.3 Predicate Device Information

Primary Predicate Device: iLase™

Manufacturer: Biolase Technology, Inc.

510(k) number: K093852

Indication of use:

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Image /page/5/Picture/1 description: The image shows the logo for SOGA. The logo is in a dark gray color, except for a small portion of the letter A, which is in green. Below the logo, there are Chinese characters.

## Dental Soft Tissue Indications:

Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

- Excisional and incisional biopsies ●
- Exposure of unerupted teeth ●
- Fibroma removal ●
- Frenectomy
- Frenotomy
- Gingival troughing for crown impressions ●
- Gingivectomy ●
- Gingivoplasty ●
- Gingival incision and excision ●
- Hemostasis and coaqulation ●
- Implant recovery
- Incision and drainage of abscess ●
- Leukoplakcia
- Operculectomy ●
- Oral papillectomies ●
- Pulpotomy ●
- Pulpotomy as an adjunct to root canal therapy ●
- Reduction of gingival hypertrophy ●
- Soft tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the ● oral mucosa.
- Vestibuloplasty ●
- Tissue retraction for impression ●

## Laser Periodontal Procedures, including:

- Laser soft tissue curettage ●
- Laser removal of diseased, infected, inflamed and necrosed soft ● tissue within the periodontal pocket

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Image /page/6/Picture/1 description: The image shows the logo for SOGA. The logo is in a dark gray color, with the letter 'A' having a green triangle in the middle. Below the logo, there are four Chinese characters in a smaller font size.

- Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility).
#### 5.4 Device Description

Principle: The semiconductor laser diode is excited by the generation power supply to generate the laser, which is effectively transmitted to the treatment site through the optical fiber tip.

Intended operator: Dental surgeon.

Component part: It is composed of laser host (including internal power system, laser drive system, optical path system, LCD screen, emergency stop button, laser) and optic fiber tip.

Sterile: The Fiber optic tip and the handpiece cover require sterilization prior to use.

#### 5.5 Indications for Use

#### Dental Soft Tissue Indications:

Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marqinal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

- Excisional and incisional biopsies ●
- Exposure of unerupted teeth ●
- Fibroma removal
- Frenectomy
- Frenotomy ●
- Gingival troughing for crown impressions ●
- Gingivectomy ●
- Gingivoplasty ●
- Gingival incision and excision ●
- Hemostasis and coagulation ●
- Implant recovery

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Image /page/7/Picture/1 description: The image shows the logo for SOGA. The logo is in a dark gray color, with the letters "SOGA" in a stylized font. Below the letters is the company's name in Chinese characters. The "A" in SOGA has a green triangle in the middle.

- Incision and drainage of abscess
- Leukoplakcia ●
- Operculectomy ●
- Oral papillectomies
- Pulpotomy ●
- Pulpotomy as an adjunct to root canal therapy
- Reduction of gingival hypertrophy ●
- Soft tissue crown lengthening ●
- Treatment of canker sores, herpetic and aphthous ulcers of the ● oral mucosa.
- Vestibuloplasty ●
- Tissue retraction for impression ●

## Laser Periodontal Procedures, including:

- Laser soft tissue curettage ●
- Laser removal of diseased, infected, inflamed and necrosed soft ● tissue within the periodontal pocket
- Sulcular debridement (removal of diseased, infected, inflamed ● and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility).

## 5.6 Comparison of Technological Characteristics with the Predicate Device

| Comparison Items | Subject Device:<br>SOGALaser<br>(Model: ILaser II) | Predicate<br>Device 1:<br>Dental<br>diode laser<br>(K093852) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification & Intended Use | | |
| Classification | GEX<br>Class II | GEX<br>Class II |
| | 21 CFR 878.4810 | 21 CFR<br>878.4810 |
| | | |
| Intended use | Intended to incision,<br>excision, vaporization,<br>ablation and coagulation<br>of oral soft tissues<br>including marginal and<br>inter-dental gingival and<br>epithelial lining of free<br>gingiva. | Incision,<br>excision,<br>vaporization,<br>ablation and<br>coagulation<br>of oral soft<br>tissues,<br>including<br>marginal and<br>inter-dental<br>gingival and<br>epithelial<br>lining of free<br>gingiva and<br>the following<br>specific<br>indications:<br>(For specific<br>refer to<br>Attachment<br>E) |
| Patient Population | For use in all patients | For use in all<br>patients |
| Environment of Use | For Dental surgeon | Prescription<br>Use - For<br>professional |
| Patient Population | No restriction on the<br>applicable population | All<br>Population |
| Comparison<br>Statement | The subject device enjoys<br>the same classification | |
| | and intended use with the | |
| | predicate device. | |
| Technological Characteristics | | |
| Principle / Method of Operation | The semiconductor laser<br>diode is excited by the<br>generation power supply<br>to generate the laser,<br>which is effectively<br>transmitted to the<br>treatment site through the<br>optical fiber treatment<br>head. | The energy<br>is delivered<br>to the<br>treatment<br>site via a<br>single-use<br>fiber optic<br>tip assembly. |
| Environment of Use | Hospital, clinic, and<br>medical office setting | Hospital,<br>clinic, and<br>medical<br>office setting |
| Size | φ18mmx200mm | 20.5 cm Χφ<br>1.90 cm |
| Shipping list | Main body, Wireless power supply, Fiber optic tip, Laser Safety Glasses (Clinician), Laser Safety Glasses (Patient), Cleaning pen, Silicon cover. Instruction | iLase Main Body, Power Supply – Charging Station, iLase Cover, iLase Rechargeable Battery, |
| | | Tip<br>Initiation<br>Blocks,<br>Laser<br>Safety<br>Glasses<br>(Clinician),<br>Laser<br>Safety<br>Glasses<br>(Patient),<br>iLase<br>Cleaning<br>Kit,<br>User<br>Manual |
| Software | MCU software | MCU software |
| Laser Class | IV (4) | IV (4) |
| Wavelength | 980nm ±20nm | 940 nm ± 10nm |
| Output Power | 3.0 W Max CW / 5.0 W Peak Power (Pulse Mode) | 3.0 W Max CW / 5.0 W Peak Power (Pulse Mode) |
| Power Accuracy | ± 5% | ± 20% |
| Pulse mode | Continuous | Continuous |
| Duty cycle | 9.09%~83.3% | 9.09%~83.3% |
| Aiming Beam | Laser diode, max 2 mW, | Laser diode, |
| | 650nm±20nm, Class 1 | max 1 mW,<br>625-670nm,<br>Class 1 |
| N.O.H.D. | 3.03 meters | 2.61 meters |
| Comparison statement | The subject device has almost the same<br>technological characteristics with the<br>predicate device, and their slight<br>difference in size, Aiming Beam and<br>Power Accuracy will not affect the core<br>usage of the devices or validated by<br>relevant standard evaluation or not<br>bringing new safety and effectiveness<br>concerns, thus will not affecting the<br>substantial equivalence comparison. their<br>differences are not affecting the core<br>usage of the devices<br><br>The difference in Wavelength verified the<br>safety characteristics by IEC 60825-1 and<br>IEC 60601-2-22, and the efficiency of the<br>subject device was able to reach an<br>equivalence level of the predicate device.<br>It could be found in the literature<br>referred.[1] | |
| Material Characteristics | | |
| Application part | Fiber optic | Fiber optic |
| Enclosure | 316L Stainless steel | Not know |
| Cover | Silica gel | Metal |
| Safety & Effectiveness | | |
| Patient-Contacting Materials | Fiber optic | Fiber optic |
| Electrical Safety | Verified according to IEC | Not know |
| | 60601-1 | |
| EMC | Verified according to IEC<br>60601-1-2 | Not know |
| Performance Safety | Verified according to IEC<br>60825-1 and IEC 60601-<br>2-22 | Not know |
| Biocompatibility | Verified according to ISO<br>10993-5 and ISO 10993-<br>10 | Not know |
| Comparison statement | The substantial equivalence of the subject<br>device has been evaluated according to<br>the FDA recognized standards. | |

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Image /page/8/Picture/0 description: The image shows the logo for SOGA. The logo is in a dark gray color, with the letter A in green. Below the logo is the company name in Chinese. The logo is simple and modern.

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Image /page/9/Picture/0 description: The image contains a logo for SOGA. The logo is in a dark gray color, except for the triangle in the letter A, which is green. Below the logo, there are four Chinese characters, which are separated by two short horizontal lines.

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Image /page/10/Picture/0 description: The image shows the logo for SOGA. The logo is in gray and green. The text below the logo is in Chinese.

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Image /page/11/Picture/0 description: The image shows the logo for SOGA. The logo is in a dark gray color, with the letter A having a green triangle in the middle. Underneath the logo is the company name in Chinese.

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Image /page/12/Picture/0 description: The image shows the logo for SOGA. The logo is in a dark gray color, and the letter A has a green triangle in the middle. Below the logo is the company name in Chinese.

## 5.6.1 Comparison summary

First, the subject device (Model: ILaser II) enjoys identical classification and intended use with the predicate device, which forms the foundation of their substantial equivalence.

Secondly, the most technological characteristics have substantial equivalence difference is below:

| Difference item |
|-----------------|
| Shipping list |
| Wavelength |
| Power Accuracy |
| Aiming Beam |
| N.O.H.D. |

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Image /page/13/Picture/0 description: The image shows the logo for SOGA, a technology company. The logo consists of the word "SOGA" in a bold, sans-serif font, with the letter "A" stylized to resemble a mountain peak. The color of the logo is primarily gray, with a small green triangle at the top of the "A". Below the word "SOGA" is the company's name in Chinese characters.

Enclosure material

Handpiece cover material

## 5.7 Discussion of Tests Performed

5.7.1 Clinical Test

Clinical testing was not performed for SOGALaser (Model: ILaser II) as part of the submission.

5.7.2 Non-Clinical Tests

The subject device was tested/analyzed according to the following standards in order to ensure substantial equivalence:

| | Standard<br>Designation<br>Number | Title of Standard |
|----------------------------------|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | IEC 60601-1 | Medical electrical<br>equipment Part 1:<br>General requirements<br>for basic safety and<br>essential performance |
| Electromagnetic<br>Compatibility | IEC 60601-1-2 | Medical Electrical<br>Equipment - Part 1-2:<br>General Requirements<br>For Basic Safety And<br>Essential Performance<br>– Collateral Standard:<br>Electromagnetic<br>Compatibility -<br>Requirements And<br>Tests |
| Performance<br>Safety and | IEC 60825-1 | Safety of laser<br>products - Part 1: |

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Image /page/14/Picture/0 description: The image shows the logo for SOGA. The logo consists of the word "SOGA" in a dark gray, sans-serif font. The "A" in "SOGA" has a green triangle in the middle. Below the word "SOGA" is the company's name in Chinese characters.

| Effectiveness | | |
|------------------|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Equipment<br>classification, and<br>requirements |
| | IEC 60601-2-22 | Medical electrical<br>equipment - Part 2-22:<br>Particular<br>requirements for basic<br>safety and essential<br>performance of<br>surgical, cosmetic,<br>therapeutic and<br>diagnostic laser<br>equipment |
| Biocompatibility | ISO 10993-5 | Biological evaluation<br>of medical devices –<br>Part 5: Tests for <i>in</i><br>vitro cytotoxicity |
| | ISO 10993-10 | Biological evaluation<br>of medical devices –<br>Part 10: Test for<br>irritation and skin<br>sensitization |

# 5.8 Conclusion

From the above analysis, it is proper to conclude that the subject device (Model: ILaser II) will be as safe and effective for usage as the listed predicate devices that have already been on the U.S. market.

5.9 Date the Summary was prepared: June 30, 2022