← Product Code [NVK](/productcode/NVK) · K253309

# SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) (K253309)

_Shenzhen Soga Technology Co., Ltd. · NVK · May 19, 2026 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K253309

## Device Facts

- **Applicant:** Shenzhen Soga Technology Co., Ltd.
- **Product Code:** [NVK](/productcode/NVK.md)
- **Decision Date:** May 19, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

Aurora-S: • Intra-oral soft tissue surgery (incision, excision, ablation, coagulation); • Leukoplakia; • Pulpotomy as adjunct to root canal retreatment; • Pulp extirpation; • Removal of fibromae; • Removal of granulated tissue; • Caries removal, cavity preparation, enamel roughening; • Sulcular debridement; • Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement; • Cutting, shaving, contouring and resection of oral osseous tissue (bone); • Osteotomy, osseous crown lengthening, osteoplasty; • Apicectomy surgery; • Removal of subgingival calculus in periodontal pockets with periodontitis by closed or open curettage; • Laser removal of porcelain and ceramic crowns and veneers; • Flap preparation – incision of soft-tissue to prepare a flap and expose the bone; • Cutting bone to prepare a window access to the apex (apices) of the root(s); • Root-end preparation for retrofill amalgam or composite; • Full thickness flap; • Partial thickness flap; • Split thickness flap; • Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; • Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium; • Excisional and incisional biopsies; • Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions); • Frenectomy and frenotomy; • Gingival troughing for crown impressions; • Gingivectomy; • Gingivoplasty; • Implant recovery; • Root canal debridement and cleaning; • Soft tissue crown lengthening; • Laser root canal disinfection after endodontic treatment ILaser III Pro: SOGA Lasers therapy system family of the Dental diode laser is intended for intra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter- dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy, operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue, laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; 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 sulcus periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; herpetic ulcers of the oral mucosa; laser soft tissue curettage.

## Device Story

SOGA Lasers therapy system (Aurora-S and ILaser III Pro) provides dental laser surgery; Aurora-S uses Er:YAG (2940 nm) and multi-wavelength diode (450/650/980 nm) lasers; ILaser III Pro uses diode lasers (450/650/980 nm). Laser energy generated via solid-state crystal or semiconductor diode; transmitted via flexible fiber optic cable to handpiece tip. Operated by clinician in dental clinic; foot switch or finger switch controls emission. Touchscreen interface displays parameters/protocols. Output enables soft/hard tissue surgery, hemostasis, and disinfection. Clinical benefit: precise tissue removal, reduced bleeding, improved periodontal indices.

## Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), performance testing (IEC 60601-2-22), biocompatibility (ISO 10993-1), and software validation (IEC 62304).

## Technological Characteristics

Dual-laser system (Er:YAG 2940nm, Diode 450/650/980nm). Fiber optic beam delivery. Touchscreen HMI. Windows-based OS. Class II/IV laser classification. Power: up to 8W (Aurora-S) or 4W (ILaser III Pro). Pulse frequency up to 50Hz (Er:YAG) or 20kHz (Diode). Sterilization: non-sterile single-use tips.

## Regulatory 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

- LightWalker Laser System Family ([K242202](/device/K242202.md))
- D-Laser Blue ([K210367](/device/K210367.md))

## Reference Devices

- D-Laser Blue ([K210367](/device/K210367.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

May 19, 2026

Shenzhen Soga Technology Co., Ltd.
Zhang Sha
Regulatory Affairs Manager
Room 102, 2nd Floor & Room 302, 3rd Floor, Building 1,
Second Industrial Zone, No. 16, Guanghui Road,
Shenzhen, Guangdong 318110
CHINA

Re: K253309
Trade/Device Name: SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser (ILaser III Pro)
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, GEX
Dated: September 27, 2025
Received: September 29, 2025

Dear Zhang Sha:

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

{1}

K253309 - Zhang Sha
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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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

{2}

K253309 - Zhang Sha
Page 3

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-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,

MICHAEL E. ADJODHA -S

Michael E. Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

{3}

|  Indications for Use  |   |   |
| --- | --- | --- |
|  Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253309 | ?  |
|  Please provide the device trade name(s). |   | ?  |
|  SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser (ILaser III Pro)  |   |   |
|  Please provide your Indications for Use below. |   | ?  |
|  Aurora-S: • Intra-oral soft tissue surgery (incision, excision, ablation, coagulation); • Leukoplakia; • Pulpotomy as adjunct to root canal retreatment; • Pulp extirpation; • Removal of fibromae; • Removal of granulated tissue; • Caries removal, cavity preparation, enamel roughening; • Sulcular debridement; • Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement; • Cutting, shaving, contouring and resection of oral osseous tissue (bone); • Osteotomy, osseous crown lengthening, osteoplasty; • Apicectomy surgery; • Removal of subgingival calculus in periodontal pockets with periodontitis by closed or open curettage; • Laser removal of porcelain and ceramic crowns and veneers; • Flap preparation – incision of soft-tissue to prepare a flap and expose the bone; • Cutting bone to prepare a window access to the apex (apices) of the root(s); • Root-end preparation for retrofill amalgam or composite; • Full thickness flap; • Partial thickness flap; • Split thickness flap; • Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; • Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium; • Excisional and incisional biopsies; • Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions); • Frenectomy and frenotomy; • Gingival troughing for crown impressions; • Gingivectomy; • Gingivoplasty; • Implant recovery; • Root canal debridement and cleaning; • Soft tissue crown lengthening; • Laser root canal disinfection after endodontic treatment  |   |   |
|  ILaser III Pro: SOGA Lasers therapy system family of the Dental diode laser is intended for intra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-  |   |   |

{4}

dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy, operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue, laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; 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 sulcus periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; herpetic ulcers of the oral mucosa; laser soft tissue curettage.

Please select the types of uses (select one or both, as applicable).

☑ Prescription Use (Part 21 CFR 801 Subpart D)

☐ Over-The-Counter Use (21 CFR 801 Subpart C)

{5}

068_Tab 16 510(k) Summary

# 510(k) Summary K253309

## 1. Administrative Information

Date of Summary prepared: September 27,2025

### 1.1 Submitter Information

- Company: Shenzhen SOGA Technology Co., Ltd.
- Address: Room 102, 2nd Floor & Room 302, 3rd Floor, Building 1, Second Industrial Zone, No. 16, Guanghui Road, Longteng Community, Shiyan Street, Bao'an District, Shenzhen, Guangdong Province, China.
- Phone: +086-18801027360
- Contact: Lisa, zhang, Regulatory Affairs Manager
- Mail box: zhangs@soga12.com

### 1.2 Device Information

- Common Name: SOGA Lasers therapy system family
- Trade/Device Name: SOGA Lasers therapy system family of the Dental diode laser, SOGA Lasers therapy system family of Aurora handpiece
- Model: ILaser III Pro, Aurora-S
- Classification regulation: Laser, Dental, Soft Tissue
- Regulation number: 21 CFR 878.4810
- Regulation Description: Laser surgical instrument for use in general and plastic surgery and in dermatology Medical
- Regulation Medical Specialty: General & Plastic Surgery
- Review Panel: Dental
- Product Code: NVK GEX
- Device Class: Class II
- Submission number: Not assigned.

### 1.3 Predicate Devices and Reference Devices

Model: Aurora-S

|  / | Predicate Device | Reference device  |
| --- | --- | --- |
|  Sponsor: | Fotona.d.o.o. | Guilin Woodpecker Medical Instrument Co., Ltd.  |
|  Device: | LightWalker Laser System Family | D-Laser Blue  |
|  510(K) Number | K242202 | K210367  |

### Model:ILaser III Pro

### Predicate Devices

|  Sponsor: | Guilin Woodpecker Medical Instrument Co., Ltd.  |
| --- | --- |

16-1

{6}

068_Tab 16 510(k) Summary

|  Sponsor: | Guilin Woodpecker Medical Instrument Co., Ltd.  |
| --- | --- |
|  Device: | D-Laser Blue  |
|  510(K) Number | K210367  |

## 1.4 Device Description

### Model: Aurora-S

The SOGA Lasers Therapy System Family (equipped with Aurora Handpiece) is based on Er:YAG (2940 nm) and multi-wavelength diode laser (450 nm, 650 nm, 980 nm) technology.

### Laser Generation Mechanism

Er:YAG Laser (2940 nm): Utilizes Er:YAG crystal as the solid-state working medium. Activated particles in the crystal absorb specific wavelength light energy (via diode-pumped excitation), inducing particle population inversion and laser emission.

Diode Lasers (450 nm, 650 nm, 980 nm): Adopt doped semiconductor diode materials as the laser medium. Natural cleavage surfaces of the diode form resonant cavities, and resonant amplification of these cavities achieves stimulated feedback, realizing directional, stable laser output.

### Beam Integration and Transmission

Both therapeutic laser beams (Er:YAG and diode lasers) are coupled into a flexible fiber optic cable and transmitted to the Aurora Handpiece tip. Disposable fiber optic tips (accessories) attach to the handpiece distal end to optimize beam shaping and target tissue delivery.

### Control and Operation System

**Output Control:** Laser energy emission is regulated by a foot switch assembly, ensuring hands-free operation during treatment.

**Human-Machine Interface:** A touchscreen displays real-time operational status (e.g., wavelength selection, power parameters) and treatment modes. Users select protocols, adjust system settings, and confirm parameters via touch input, achieving intuitive control of the dual laser system.

It integrates dual laser generation modules, power supply, control device, laser transmission components, and cooling system within a single enclosure, forming an integrated therapeutic platform.

### Model: ILaser III Pro:

The main components of ILaser III Pro are dental diode lasers with wavelengths of 450nm, 650nm, and 980nm. 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.

## 1.5 Indications for Use

|  NO. | Aurora-S | ILaser III Pro  |
| --- | --- | --- |
|  1 | Intra-oral soft tissue surgery (incision, excision, ablation, coagulation) | frenectomy frenotomy  |
|  2 | Leukoplakia | biopsy operculectomy  |
|  3 | Pulpotomy as adjunct to root canal retreatment | implant recovery  |
|  4 | Pulp extirpation | gingivectomy gingivoplasty  |

16-1

{7}

068_Tab 16 510(k) Summary

|  NO. | Aurora-S | ILaser III Pro  |
| --- | --- | --- |
|  5 | Removal of fibromae | gingival troughing  |
|  6 | Removal of granulated tissue | crown lengthening  |
|  7 | Caries removal, cavity preparation, enamel roughening | hemostasis of donor site  |
|  8 | Sulcular debridement | removal of granulation tissue  |
|  9 | Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement | laser assisted flap surgery  |
|  10 | Cutting, shaving, contouring and resection of oral osseous tissue (bone) | debridement of diseased epithelial lining  |
|  11 | Osteotomy, osseous crown lengthening, osteoplasty | incisions and draining of abscesses  |
|  12 | Apicectomy surgery | tissue retraction for impressions  |
|  13 | Removal of subgingival calculus in periodontal pockets with periodontitis by closed or open curettage | papillectomy vestibuloplasty  |
|  14 | Laser removal of porcelain and ceramic crowns and veneers | excision of lesions  |
|  15 | Flap preparation – incision of soft-tissue to prepare a flap and expose the bone | exposure of unerupted/partially erupted teeth  |
|  16 | Cutting bone to prepare a window access to the apex (apices) of the root(s) | removal of hyperplastic tissues  |
|  17 | Root-end preparation for retrofill amalgam or composite | treatment of aphthous ulcers  |
|  18 | Full thickness flap | leukoplakia  |
|  19 | Partial thickness flap | pulpotomy pulpotomy as adjunct to root canal therapy  |
|  20 | Split thickness flap | fibroma removal  |
|  21 | Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket | gingival incision and excision  |
|  22 | Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium | treatment of canker sores  |
|  23 | Excisional and incisional biopsies | herpetic ulcers of the oral mucosa  |
|  24 | Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) | laser soft tissue curettage  |
|  25 | Frenectomy and frenotomy | reduction of gingival hypertrophy.  |
|  26 | Gingival troughing for crown impressions | laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket  |
|  27 | Gingivectomy | 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 inability)  |
|  28 | Gingivoplasty | /  |
|  29 | Implant recovery | /  |

16-1

{8}

068 Tab 16 510(k) Summary

|  NO. | Aurora-S | ILaser III Pro  |
| --- | --- | --- |
|  30 | Root canal debridement and cleaning | /  |
|  31 | Soft tissue crown lengthening | /  |
|  32 | Laser root canal disinfection after endodontic treatment | /  |

16-1

{9}

068 Tab 16 510(k) Summary

## 1.6 Comparison with Predicate Decision

### 1.6.1 Comparison of the Indications for Use

Table 1 Comparison Between the Indications for Use and Technological Characteristics of Aurora-S and those of the Predicate and Reference Devices

|  Proposed Device | Predicate Device | Reference Device | Discussion of the differences between proposed device and predicate device  |
| --- | --- | --- | --- |
|  Shenzhen SOGA Technology Co., Ltd. | Fotona.d.o.o. | Guilin Woodpecker Medical Instrument Co., Ltd. | /  |
|  Product Code |   |   |   |
|  NVK, GEX | GEX | NVK, GEX, ILY |   |
|  Aurora-S | LightWalker Laser System Family | D-Laser Blue | /  |
|  Regulation Number |   |   |   |
|  21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |   |
|  Classification |   |   |   |
|  Class II | Class II | Class II |   |
|  Surgical Indication for Use |   |   |   |
|  Intended for the incision, excision, cutting, ablation, and vaporization of soft and hard tissues in dental and oral surgery, and dentistry. | Er:YAG laser (2940 nm wavelength) in dentistry: | Intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter dental and epithelial lining of free gingiva and is indicated for: | /  |
|  Leukoplakia | Leukoplakia | Leukoplakia | /  |

{10}

068 Tab 16 510(k) Summary

|  Pulpotomy as adjunct to root canal retreatment | Pulpotomy as adjunct to root canal retreatment | Pulpotomy as adjunct to root canal retreatment | /  |
| --- | --- | --- | --- |
|  Pulp extirpation | Pulp extirpation | N/A | /  |
|  Removal of fibromae | Removal of fibromae | Fibroma removal | /  |
|  Removal of granulated tissue | Removal of granulated tissue | Removal of granulation tissue | /  |
|  Caries removal, cavity preparation, enamel roughening | Caries removal, cavity preparation, enamel roughening | N/A | /  |
|  Sulcular debridement | Sulcular debridement | Sulcular debridement | /  |
|  Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement | Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement | N/A | /  |
|  Cutting, shaving, contouring and resection of oral osseous tissue (bone) | Cutting, shaving, contouring and resection of oral osseous tissue (bone) | N/A | /  |
|  Osteotomy, osseous crown lengthening, osteoplasty | Osteotomy, osseous crown lengthening, osteoplasty | N/A | /  |
|  Apicectomy surgery | Apicectomy surgery | N/A | /  |
|  Removal of subgingival calculus in periodontal pockets with periodontitis by closed or open curettage | Removal of subgingival calculus in periodontal pockets with periodontitis by closed or open curettage | N/A | /  |
|  Laser removal of porcelain and ceramic crowns and veneers | Laser removal of porcelain and ceramic crowns and veneers | N/A | /  |
|  Flap preparation – incision of soft-tissue to prepare a flap and expose the bone; | Flap preparation – incision of soft-tissue to prepare a flap and expose the bone; | N/A | /  |
|  Cutting bone to prepare a window access to the apex (apices) of the root(s) | Cutting bone to prepare a window access to the apex (apices) of the root(s) | N/A | /  |

2 / 15
16-1

{11}

068 Tab 16 510(k) Summary

|  Root-end preparation for retrofill amalgam or composite | Root-end preparation for retrofill amalgam or composite | N/A | /  |
| --- | --- | --- | --- |
|  Full thickness flap | Full thickness flap | N/A | /  |
|  Partial thickness flap | Partial thickness flap | N/A | /  |
|  Split thickness flap | Split thickness flap | N/A | /  |
|  Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket | Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket | N/A | /  |
|  Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium | Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium | N/A | /  |
|  Excisional and incisional biopsies | Excisional and incisional biopsies | N/A | /  |
|  Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) | Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) | N/A | /  |
|  Frenectomy and frenotomy | Frenectomy and frenotomy | Frenectomy and frenotomy | /  |
|  Gingival troughing for crown impressions | Gingival troughing for crown impressions | Gingival troughing | /  |
|  Gingivectomy | Gingivectomy | Gingivectomy | /  |
|  Gingivoplasty | Gingivoplasty | Gingivoplasty | /  |
|  Implant recovery | Implant recovery | Implant recovery | /  |
|  Root canal debridement and cleaning | Root canal debridement and cleaning | N/A | /  |
|  Soft tissue crown lengthening | Soft tissue crown lengthening | N/A | /  |
|  Laser root canal disinfection after endodontic treatment | Laser root canal disinfection after endodontic treatment | N/A | /  |

3 / 15
16-1

{12}

068 Tab 16 510(k) Summary

Table 2 Comparison Between the Indications for Use of ILaser III Pro and those of the Predicate device.

|  Proposed Device | Predicate Device | Discussion of the differences between proposed device and predicate device  |
| --- | --- | --- |
|  Shenzhen SOGA Technology Co., Ltd. | Guilin Woodpecker |   |
|  ILaser III Pro | D-Laser Blue  |   |
|  Surgical Indication for Use  |   |   |
|  Intended for intraand extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter dental and epithelial lining of free gingiva and is indicated for: | Intended for intraand extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter dental and epithelial lining of free gingiva and is indicated for: | SAME  |
|  frenectomy; frenotomy; | frenectomy; frenotomy; | SAME  |
|  biopsy; operculectomy; | biopsy; operculectomy; | SAME  |
|  implant recovery; | implant recovery; | SAME  |
|  gingivectomy; gingivoplasty | gingivectomy; gingivoplasty | SAME  |
|  gingival troughing; | gingival troughing; | SAME  |
|  crown lengthening; | crown lengthening; | SAME  |
|  hemostasis of donor site; | hemostasis of donor site; | SAME  |
|  removal of granulation tissue; | removal of granulation tissue; | SAME  |
|  laser assisted flap surgery; | laser assisted flap surgery; | SAME  |
|  debridement of diseased epithelial lining; | debridement of diseased epithelial lining; | SAME  |
|  incisions and draining of abscesses; | incisions and draining of abscesses; | SAME  |

{13}

068 Tab 16 510(k) Summary

|  Proposed Device | Predicate Device | Discussion of the differences between proposed device and predicate device  |
| --- | --- | --- |
|  tissue retraction for impressions; | tissue retraction for impressions; | SAME  |
|  papillectomy; vestibuloplasty; | papillectomy; vestibuloplasty; | SAME  |
|  excision of lesions; | excision of lesions; | SAME  |
|  exposure of unerupted/partially erupted teeth; | exposure of unerupted/partially erupted teeth; | SAME  |
|  removal of hyperplastic tissues; | removal of hyperplastic tissues; | SAME  |
|  treatment of aphthous ulcers; | treatment of aphthous ulcers; | SAME  |
|  leukoplakia; | leukoplakia; | SAME  |
|  pulpotomy; pulpotomy as adjunct to root canal therapy; | pulpotomy; pulpotomy as adjunct to root canal therapy; | SAME  |
|  fibroma removal; | fibroma removal; gingival | SAME  |
|  gingival incision and excision; | gingival incision and excision; | SAME  |
|  treatment of canker sores; | treatment of canker sores; | SAME  |
|  herpetic ulcers of the oral mucosa; | herpetic ulcers of the oral mucosa; | SAME  |
|  laser soft tissue curettage; | laser soft tissue curettage; | SAME  |
|  reduction of gingival hypertrophy. | reduction of gingival hypertrophy. | SAME  |
|  Laser Periodontic Indications for Use |   |   |
|  laser removal of diseased, infected, inflamed and necrosed soft tissue; within the periodontal pocket; | laser removal of diseased, infected, inflamed and necrosed soft tissue; within the periodontal pocket; | SAME  |
|  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 inability) | 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 inability) | SAME  |

16-1

{14}

068 Tab 16 510(k) Summary

|  Proposed Device | Predicate Device | Discussion of the differences between proposed device and predicate device  |
| --- | --- | --- |
|  attachment loss and tooth inability) |  |   |
|  Tooth Whitening Indications for Use |   |   |
|  / | light activation for bleaching materials for teeth whitening | The device has no indications for whitening  |
|   | laser-assisted whitening/bleaching of teeth |   |
|  Low Level Laser Therapy Indications for Use |   |   |
|  / | intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasms, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. | The device has no indications for Therapy  |

## 1.6.2 Comparison of the technological characteristics

Table 3 Comparison Between the Technological Characteristics of Aurora-S and those of the Predicate and Reference Devices

|  Item | Proposed Device: SOGA Lasers therapy system family (Model: Aurora-S) |   | Predicate Device: LightWalker Laser System Family (K242202) | Reference Devices (Model: D-Laser Blue) (K210367) | Discussion of the differences between proposed device and predicate device  |
| --- | --- | --- | --- | --- | --- |
|  User Interface | Touchscreen |   | Touchscreen | Touchscreen | SAME  |
|  Laser Type | Er: YAG laser | Diode laser | Er: YAG laser | Diode laser | SAME  |
|  Wavelength | 2940 nm | 450±20nm 650±20nm 980±20nm | 2940 nm | 980±20nm 650 nm±20nm 450 nm±10nm | SAME  |

{15}

068 Tab 16 510(k) Summary

|  Laser output Mode | Pulsed |   | Pulsed | Pulsed | SAME  |
| --- | --- | --- | --- | --- | --- |
|  Pulse Width | 25μs-1000μs | 5μs to 0.9s | 0.025 – 1 ms | 5μs – 0.9 s | SAME  |
|  Pulse Frequency | Up to 50Hz | 1Hz~20kHz | Up to 50 Hz | 1Hz~20kHz | SAME  |
|  Power | Up to 8W | 980nm: 0.2 W -4W (Continuous Wave) 7 W (peak power) | Up to 20 W | 976 nm: 0.2 W - 4 W (Continuous Wave) 7 W (peak power) | The proposed device is within the predicate device.  |
|   |   |  650nm: 25 mW -200mW (Continuous Wave) |   | 650 nm: 25 mW-200 mW (Continuous Wave)  |   |
|   |   |  450nm: 0.2W -3.0mW (Continuous Wave) 4 W (peak power) |   | 450 nm: 0.2 W -3.0 W (Continuous Wave) 4 W (peak power)  |   |
|  Pulse energy | Up to 500mJ | N/A | Up to 1.5 J | N/A | The proposed device is within the predicate device and reference device.  |

16-1

{16}

068 Tab 16 510(k) Summary

|  Beam Delivery | Fiber optic tip | Articulated Arm | Optical Fiber Surgical Tips | 1.Fiber optic tip is equal to Optical Fiber Surgical Tips, It's just a difference in naming; 2.Although Fiber optic tip is different from Articulated Arm, the core function of both is to transfer the laser energy from the laser generator to the treatment area without directional deviation. Both can prevent the leakage of erbium laser energy and are compatible with the host and treatment handheld device.  |
| --- | --- | --- | --- | --- |
|  User interface | Touchscreen | Touchscreen | Color touch screen graphical user interface | SAME  |
|  Operating system | Windows | Windows | Windows | SAME  |

Table 4 Comparison Between the Technological Characteristics of ILaser III Pro and those of the Predicate Device

|  Item | Proposed Device | Predicate Device | Discussion of the differences between proposed device and predicate device  |
| --- | --- | --- | --- |
|  510(k) Number | / | K210367 | /  |
|  Model | ILaser III Pro | D-Laser Blue  |   |
|  Product Code | NVK, GEX | NVK, GEX, ILY  |   |
|  Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME  |

{17}

068 Tab 16 510(k) Summary

|  Number |  |  |   |
| --- | --- | --- | --- |
|  Classification | II | II | SAME  |
|  Application | Dental laser | Dental laser | SAME  |
|  Laser Classification | 980 nmand 450nm Laser: Class IV 650 nm Laser: Class II | 976 nm and 450nm Laser: Class IV 650 nm Laser: Class II | SAME  |
|  Laser Type | Solid state diode | Solid state diode | SAME  |
|  Laser Wavelength | 980±20nm 650 nm±20nm 450 nm±10nm | 976 nm (+/-20 nm) (956-996) 650 nm (+/-20 nm) (630-670) 450 nm (+/-20 nm) (430-470) | SAME  |
|  Optical Power | 980nm: 0.2 W -4W (Continuous Wave) 7 W (peak power) 650 nm: 25 mW-200 mW (Continuous Wave) 450 nm: 0.2 W -3.0 W (Continuous Wave) 4 W (peak power) | 976nm: 0.2 W -4 W (Continuous Wave) 7 W (peak power) 650 nm: 25 mW-200 mW (Continuous Wave) 450 nm: 0.2 W -3.0 W (Continuous Wave) 4 W (peak power) | SAME  |
|  Emission Modalities | Continuous Wave; 1 Hz – 20 kHz | Continuous Wave; 1 Hz – 20 kHz | SAME  |
|  Pulse Duration | 5us – 0.9s | 5us – 0.9s | SAME  |
|  Aiming Beam | 650±20 nm, Pmax< 5 mW | 650±20 nm, Pmax< 5 mW | SAME  |
|  Optical Fiber Surgical Tips |  |   |   |
|  Fiber Diameter: | 0.2mm+0.1mm,0.4mm+0.1 mm | 200 μm, 300 μm, 400 μm, | SAME  |

16-1

{18}

068 Tab 16 510(k) Summary

|  Item | Proposed Device | Predicate Device | Discussion of the differences between proposed device and predicate device  |
| --- | --- | --- | --- |
|  Surgical Tips | Single-use tips. Provided non sterile | Single-use tips. Provided non sterile | SAME  |
|  User Interface | Color touch screen graphical user interface | Color touch screen graphical user interface | SAME  |
|  Activation Method | Handpiece finger switch | Handpiece finger switch; Footswitch | Difference, analysis 1 The difference could refer to the Usability testing report and IEC60601-1 testing report.  |
|  Delivery System | Fiber optic cable, handpiece, accessories. | Fiber optic cable, handpiece, accessories. | SAME  |
|  Laser Control Unit Dimensions | 220mm x 277mm x 168mm | 190 mm x 180 mm x 200 mm | The minor difference could affect the safety and performance.  |

## 2. Brief discussion of the non-clinical tests

To verify the performance requirements of Aurora-S and ILaser III Pro, the following tests were performed.

It shows that the testing results do support substantial equivalence.

- Verify the conformity of the proposed devices with the requirements of IEC 60601-1: (Medical electrical equipment Part 1: General requirements for basic safety and essential performance).
- Verify the conformity of the proposed devices with the requirements of IEC 60601-1-2: (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic compatibility) and IEC TR 60601-4-2:2016 (Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems).
- Verify the conformity of the proposed devices to IEC 60825-1 (Safety of laser products - Part 1: Equipment classification and requirements).
- Verify the performance of the proposed devices according to IEC 60601-2-22: (Medical electrical equipment Part 2: Particular Requirements for

16-1

{19}

068 Tab 16 510(k) Summary

basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment).

- Conduct usability study in conformity with IEC 62366 (Medical devices - Application of usability engineering to medical devices).
- Validate the devices' software in conformity with IEC 62304 (Medical device software - Software lifecycle processes).
- Evaluate the biocompatibility of patient contacting components of the proposed devices according to the requirements ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).
- Validate the devices' Reprocessing of the proposed device according to ISO 17664 -1 (Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices) and ISO 17665 (Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices)
- Perform the performance testing;

## 3. Clinical Testing Performed

No clinical testing was performed.

## 4. Other information (such as required by FDA guidance/Test)

N/A

## 5. 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, Shenzhen soga Technology Co.,LTD. concludes that:

- The indications for use of Aurora-S and ILaser III Pro are totally same as those of the predicate devices.
- The technological characteristic differences between Aurora-S and LightWalker Laser System Family, and between and ILaser III Pro and D-Laser Blue do not affect the substantial equivalence, so no new risk is raised.
- Demonstrated by the safety and performance tests, the characteristics of Aurora-S and ILaser III Pro are respectively equivalent to those of the predicate devices.

---

**Source:** [https://fda.innolitics.com/device/K253309](https://fda.innolitics.com/device/K253309)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com