(438 days)
Not Found
No
The device description focuses on the laser technology and its components, with no mention of AI or ML. The performance studies are based on non-clinical tests and recognized standards, not on data-driven performance metrics typically associated with AI/ML.
Yes.
The device's intended uses, such as "incision, excision, vaporization, ablation and coagulation of oral soft tissues" and treating various dental conditions, directly indicate its role in treating or mitigating disease, injury, or conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The device description and intended use focus on therapeutic applications (incision, excision, vaporization, ablation, coagulation, etc.) rather than diagnosis or detection of medical conditions.
No
The device description explicitly states it is composed of a "laser host" and "optic fiber tip," which are hardware components. The principle of operation involves a semiconductor laser diode generating a laser transmitted through an optical fiber. This is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The description clearly states the device is a semiconductor laser diode used for surgical procedures on oral soft tissues. It performs actions like incision, excision, vaporization, ablation, and coagulation. These are direct interventions on the patient's body, not tests on samples.
- Intended Use: The intended use lists various dental surgical procedures, all of which involve treating tissues within the mouth.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or provide diagnostic information based on laboratory tests.
Therefore, this device is a surgical laser intended for direct treatment of oral soft tissues, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
NVK, GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissues, periodontal pocket
Indicated Patient Age Range
For use in all patients, No restriction on the applicable population
Intended User / Care Setting
Dental surgeon. Hospital, clinic, and medical office setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests were performed to ensure substantial equivalence. The subject device was tested/analyzed according to the following standards: Electrical Safety (IEC 60601-1), Electromagnetic Compatibility (IEC 60601-1-2), Performance Safety and Effectiveness (IEC 60825-1, IEC 60601-2-22), Biocompatibility (ISO 10993-5, ISO 10993-10). Clinical testing was not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known) K211150
Device Name
Dental Diode Laser, SOGA Laser, ILaser II
| Indications for Use ( Describe ) |
|---|
| 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 ( 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.
3
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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: +086-15915873605 ●
- Contact: Tse Adrian, Quality Manager
- Mail box: 15915873605@Soga12.com ●
- 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:
SOGALaser
(Model: ILaser II) | Predicate
Device 1:
Dental
diode laser
(K093852) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification & Intended Use | | |
| Classification | GEX
Class II | GEX
Class II |
| | 21 CFR 878.4810 | 21 CFR
878.4810 |
| | | |
| Intended use | Intended to incision,
excision, vaporization,
ablation and coagulation
of oral soft tissues
including marginal and
inter-dental gingival and
epithelial lining of free
gingiva. | 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:
(For specific
refer to
Attachment
E) |
| Patient Population | For use in all patients | For use in all
patients |
| Environment of Use | For Dental surgeon | Prescription
Use - For
professional |
| Patient Population | No restriction on the
applicable population | All
Population |
| Comparison
Statement | The subject device enjoys
the same classification | |
| | and intended use with the | |
| | predicate device. | |
| Technological Characteristics | | |
| Principle / Method of Operation | 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 treatment
head. | The energy
is delivered
to the
treatment
site via a
single-use
fiber optic
tip assembly. |
| Environment of Use | Hospital, clinic, and
medical office setting | Hospital,
clinic, and
medical
office setting |
| Size | φ18mmx200mm | 20.5 cm Χφ
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
Initiation
Blocks,
Laser
Safety
Glasses
(Clinician),
Laser
Safety
Glasses
(Patient),
iLase
Cleaning
Kit,
User
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,
625-670nm,
Class 1 |
| N.O.H.D. | 3.03 meters | 2.61 meters |
| Comparison statement | The subject device has almost the same
technological characteristics with the
predicate device, and their slight
difference in size, Aiming Beam and
Power Accuracy will not affect the core
usage of the devices or validated by
relevant standard evaluation or not
bringing new safety and effectiveness
concerns, thus will not affecting the
substantial equivalence comparison. their
differences are not affecting the core
usage of the devices
The difference in Wavelength verified the
safety characteristics by IEC 60825-1 and
IEC 60601-2-22, and the efficiency of the
subject device was able to reach an
equivalence level of the predicate device.
It could be found in the literature
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
60601-1-2 | Not know |
| Performance Safety | Verified according to IEC
60825-1 and IEC 60601-
2-22 | Not know |
| Biocompatibility | Verified according to ISO
10993-5 and ISO 10993-
10 | Not know |
| Comparison statement | The substantial equivalence of the subject
device has been evaluated according to
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
Designation
Number | Title of Standard |
|----------------------------------|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | IEC 60601-1 | Medical electrical
equipment Part 1:
General requirements
for basic safety and
essential performance |
| Electromagnetic
Compatibility | IEC 60601-1-2 | Medical Electrical
Equipment - Part 1-2:
General Requirements
For Basic Safety And
Essential Performance
– Collateral Standard:
Electromagnetic
Compatibility -
Requirements And
Tests |
| Performance
Safety and | IEC 60825-1 | Safety of laser
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 | ||
| classification, and | ||
| requirements | ||
| IEC 60601-2-22 | Medical electrical | |
| equipment - Part 2-22: | ||
| Particular | ||
| requirements for basic | ||
| safety and essential | ||
| performance of | ||
| surgical, cosmetic, | ||
| therapeutic and | ||
| diagnostic laser | ||
| equipment | ||
| Biocompatibility | ISO 10993-5 | Biological evaluation |
| of medical devices – | ||
| Part 5: Tests for in | ||
| vitro cytotoxicity | ||
| ISO 10993-10 | Biological evaluation | |
| of medical devices – | ||
| Part 10: Test for | ||
| irritation and skin | ||
| 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